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ENDOSKELETON® TCS

Model 5366-1408 · MEDTRONIC SOFAMOR DANEK, INC. · DI 00191375010968

ODP — Intervertebral Fusion Device With Bone Graft, Cervical · Class II · 21 CFR 888.3080

OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical · Class II · 21 CFR 888.3080

UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

13462019-01: 0 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1.5/device2019-04: 0 reports for this device; peer average 1.5/device2019-05: 0 reports for this device; peer average 1.55/device2019-06: 0 reports for this device; peer average 1.2/device2019-07: 0 reports for this device; peer average 1.79/device2019-08: 0 reports for this device; peer average 4.29/device2019-09: 0 reports for this device; peer average 1.57/device2019-10: 0 reports for this device; peer average 2.93/device2019-11: 0 reports for this device; peer average 1.25/device2019-12: 0 reports for this device; peer average 1.33/device2020-01: 0 reports for this device; peer average 5.78/device2020-02: 0 reports for this device; peer average 1.5/device2020-03: 0 reports for this device; peer average 1.38/device2020-04: 0 reports for this device; peer average 1.36/device2020-05: 0 reports for this device; peer average 1.46/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1.75/device2020-08: 0 reports for this device; peer average 1.31/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 1.6/device2020-11: 0 reports for this device; peer average 1.2/device2020-12: 0 reports for this device; peer average 1.71/device2021-01: 0 reports for this device; peer average 1.25/device2021-02: 0 reports for this device; peer average 2.83/device2021-03: 0 reports for this device; peer average 1.6/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 3.33/device2021-06: 0 reports for this device; peer average 3.6/device2021-07: 0 reports for this device; peer average 1.17/device2021-08: 0 reports for this device; peer average 1.4/device2021-09: 0 reports for this device; peer average 1.78/device2021-10: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1.58/device2022-01: 0 reports for this device; peer average 1.22/device2022-02: 0 reports for this device; peer average 1.44/device2022-03: 0 reports for this device; peer average 1.44/device2022-04: 0 reports for this device; peer average 1.08/device2022-05: 0 reports for this device; peer average 1.65/device2022-06: 0 reports for this device; peer average 1.64/device2022-07: 0 reports for this device; peer average 1.21/device2022-08: 0 reports for this device; peer average 1.27/device2022-09: 0 reports for this device; peer average 2.07/device2022-10: 0 reports for this device; peer average 1.3/device2022-11: 0 reports for this device; peer average 1.56/device2022-12: 0 reports for this device; peer average 1.71/device2023-01: 0 reports for this device; peer average 3/device2023-02: 0 reports for this device; peer average 1.82/device2023-03: 0 reports for this device; peer average 2.37/device2023-04: 0 reports for this device; peer average 1.44/device2023-05: 0 reports for this device; peer average 1.4/device2023-06: 0 reports for this device; peer average 1.29/device2023-07: 0 reports for this device; peer average 1.25/device2023-08: 0 reports for this device; peer average 3.35/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1.78/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1.4/device2024-01: 0 reports for this device; peer average 1.88/device2024-02: 0 reports for this device; peer average 1.5/device2024-03: 0 reports for this device; peer average 1.75/device2024-04: 0 reports for this device; peer average 1.6/device2024-05: 0 reports for this device; peer average 1.69/device2024-06: 0 reports for this device; peer average 2.75/device2024-07: 0 reports for this device; peer average 1.33/device2024-08: 0 reports for this device; peer average 1.64/device2024-09: 0 reports for this device; peer average 1.6/device2024-10: 0 reports for this device; peer average 1.38/device2024-11: 0 reports for this device; peer average 1.38/device2024-12: 0 reports for this device; peer average 1.55/device2025-01: 0 reports for this device; peer average 1.47/device2025-02: 0 reports for this device; peer average 1.93/device2025-03: 0 reports for this device; peer average 1.95/device2025-04: 0 reports for this device; peer average 1.81/device2025-05: 0 reports for this device; peer average 1.46/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 2.21/device2025-08: 0 reports for this device; peer average 1.55/device2025-09: 0 reports for this device; peer average 1.57/device2025-10: 0 reports for this device; peer average 1.53/device2025-11: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 1.55/device2026-01: 0 reports for this device; peer average 1.53/device2026-02: 0 reports for this device; peer average 1.53/device2026-03: 0 reports for this device; peer average 1.59/device2026-04: 0 reports for this device; peer average 1.3/device2026-05: 0 reports for this device; peer average 2.67/device2026-06: 0 reports for this device; peer average 2.81/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0201
2019-0301.5
2019-0401.5
2019-0501.55
2019-0601.2
2019-0701.79
2019-0804.29
2019-0901.57
2019-1002.93
2019-1101.25
2019-1201.33
2020-0105.78
2020-0201.5
2020-0301.38
2020-0401.36
2020-0501.46
2020-0601
2020-0701.75
2020-0801.31
2020-0902
2020-1001.6
2020-1101.2
2020-1201.71
2021-0101.25
2021-0202.83
2021-0301.6
2021-0401
2021-0503.33
2021-0603.6
2021-0701.17
2021-0801.4
2021-0901.78
2021-1001
2021-1101
2021-1201.58
2022-0101.22
2022-0201.44
2022-0301.44
2022-0401.08
2022-0501.65
2022-0601.64
2022-0701.21
2022-0801.27
2022-0902.07
2022-1001.3
2022-1101.56
2022-1201.71
2023-0103
2023-0201.82
2023-0302.37
2023-0401.44
2023-0501.4
2023-0601.29
2023-0701.25
2023-0803.35
2023-0901
2023-1001.78
2023-1101
2023-1201.4
2024-0101.88
2024-0201.5
2024-0301.75
2024-0401.6
2024-0501.69
2024-0602.75
2024-0701.33
2024-0801.64
2024-0901.6
2024-1001.38
2024-1101.38
2024-1201.55
2025-0101.47
2025-0201.93
2025-0301.95
2025-0401.81
2025-0501.46
2025-0602
2025-0702.21
2025-0801.55
2025-0901.57
2025-1001.53
2025-1102
2025-1201.55
2026-0101.53
2026-0201.53
2026-0301.59
2026-0401.3
2026-0502.67
2026-0602.81
This device (reports/month)Average device in ODP, OVE (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K142940 — cites (transitively): K072415 (d1), K073285 (d1), K091088 (d1), K100889 (d1), K113252 (d1), K113559 (d1), K120819 (d1), K133494 (d1), K082801 (d2), P980048 (d2), K094042 (d2), K071833 (d2), P000028 (d2), K092211 (d2), K120031 (d2), K122630 (d2), K062083 (d3), K072253 (d3), K082698 (d3), K083475 (d3), K080971 (d3), K092070 (d3) — cited as predicate by K151596, K153122, K191565

K151596 — cites (transitively): K142940 (d1), K072415 (d2), K073285 (d2), K091088 (d2), K100889 (d2), K113252 (d2), K113559 (d2), K120819 (d2), K133494 (d2), K082801 (d3), P980048 (d3), K094042 (d3), K071833 (d3), P000028 (d3), K092211 (d3), K120031 (d3), K122630 (d3), K062083 (d4), K072253 (d4), K082698 (d4), K083475 (d4), K080971 (d4), K092070 (d4) — cited as predicate by K153122, K160066, K173535

K173535 — cites (transitively): K142589 (d1), K148529 (d1), K151596 (d1), K153122 (d1), K163269 (d1), K032812 (d2), K080615 (d2), K083714 (d2), K100889 (d2), K102067 (d2), K111626 (d2), K140055 (d2), K142940 (d2), K141953 (d2), K073109 (d2), K123045 (d2), K082801 (d3), P980048 (d3), P950002 (d3), P950019 (d3), P960025 (d3), K071795 (d3), K072415 (d3), K073285 (d3), K091088 (d3), K113252 (d3), K113559 (d3), K120819 (d3), K133494 (d3), K094042 (d4), K071833 (d4), P000028 (d4), K092211 (d4), K120031 (d4), K122630 (d4), K062083 (d5), K072253 (d5), K082698 (d5), K083475 (d5), K080971 (d5), K092070 (d5) — cited as predicate by K183557, K191565, K191581, K192018, K192054

K183557 — cites (transitively): K032812 (d1), K141953 (d1), K170399 (d1), K170676 (d1), K171686 (d1), K172676 (d1), K173535 (d1), K180364 (d1), K080615 (d2), K083714 (d2), K100889 (d2), K102067 (d2), K111626 (d2), K140055 (d2), K150481 (d2), K160125 (d2), P950019 (d2), P960025 (d2), K072253 (d2), K072791 (d2), K160547 (d2), K120570 (d2), K153107 (d2), K162103 (d2), K081611 (d2), K120603 (d2), K140003 (d2), K162138 (d2), K163230 (d2), K163491 (d2), K142589 (d2), K148529 (d2), K151596 (d2), K153122 (d2), K163269 (d2), K120275 (d2), K162264 (d2), K171496 (d2), K082801 (d3), P980048 (d3), P950002 (d3), K073109 (d3), K073285 (d3), K100214 (d3), K050553 (d3), K072465 (d3), K091426 (d3), K111123 (d3), K123206 (d3), K082698 (d3), K100945 (d3), K110843 (d3), K112316 (d3), K113138 (d3), K113561 (d3), K130699 (d3), K133614 (d3), K141405 (d3), K142940 (d3), K073669 (d3), K100210 (d3), K120991 (d3), K123997 (d3), K140142 (d3), K143740 (d3), K072991 (d3), K103169 (d3), K133494 (d3), K150362 (d3), K152304 (d3), K153495 (d3), K140319 (d3), K160916 (d3), K141665 (d3), K161230 (d3), K123045 (d3), K101171 (d3), K142251 (d3), K152532 (d3), K160924 (d3), K162262 (d3), K073177 (d4), K090425 (d4), K091088 (d4), K092336 (d4), P000028 (d4), K080401 (d4), K081917 (d4), K101302 (d4), K051454 (d4), K063399 (d4), K080024 (d4), K080699 (d4), K083626 (d4), K083894 (d4), K073202 (d4), K071795 (d4), K043479 (d4), K031672 (d4), K092211 (d4), K120031 (d4), K122630 (d4), K062151 (d4), K110632 (d4), K113348 (d4), K122967 (d4), K132601 (d4), K071724 (d4), K081968 (d4), K100089 (d4), K131372 (d4), K090816 (d4), K120918 (d4), K123231 (d4), K130820 (d4), K131082 (d4), K133455 (d4), K120486 (d4), K130177 (d4), K072415 (d4), K113252 (d4), K113559 (d4), K120819 (d4), K140921 (d4), K142050 (d4), K142264 (d4), K060506 (d4), K123486 (d4), K132624 (d4), K143393 (d4), K143616 (d4), K072981 (d4), K102606 (d4), K133328 (d4), K142066 (d4), K150053 (d4), K082262 (d4), K090507 (d4), K110327 (d4), K113285 (d4), K142645 (d4), K150643 (d4), K152475 (d4), K153782 (d4), K150788 (d4), K151310 (d4), K151322 (d4), K141896 (d4), K153419 (d4), K160051 (d4), K151726 (d4), K160955 (d4), K073348 (d5), K094042 (d5), K103382 (d5), K031635 (d5), K080568 (d5), K101923 (d5), K062083 (d5), K083475 (d5), K071833 (d5), K080971 (d5), K092070 (d5), K080537 (d5), K072160 (d5), K023570 (d5), K062933 (d5), K073291 (d5), K082310 (d5), K091278 (d5), K092193 (d5), K100042 (d5), K090064 (d5), K130548 (d5), K031729 (d5), K040267 (d5), K042883 (d5), K042993 (d5), K051146 (d5), K051380 (d5), K051977 (d5), K053514 (d5), K061521 (d5), K072221 (d5), K072575 (d5), K123166 (d5), K043206 (d5), K133623 (d5), K123027 (d5), K140659 (d5), K082014 (d5), K120869 (d5), K131276 (d5), K133650 (d5), K053340 (d5), K100391 (d5), K101301 (d5), K141942 (d5), K080281 (d5), K081614 (d5), K122989 (d5), K132700 (d5), K151472 (d5), K143163 (d5), K103111 (d5), K121649 (d5), K150994 (d5), K100043 (d5), K131723 (d5), K140479 (d5), P970015 (d6), K042871 (d6), K052888 (d6), K082252 (d6), K093242 (d6), K073470 (d6), K101812 (d6), K040482 (d6), K040928 (d6), K082406 (d6), K083026 (d6), K090899 (d6), K092574 (d6), K082732 (d6), K050539 (d6), K063423 (d6), K974556 (d6), K092901 (d6), K090353 (d6), K121760 (d6), K101310 (d6), K102090 (d6), K111122 (d6), K133200 (d6), K133286 (d6), K083661 (d6), K093704 (d6), K093864 (d6), K100865 (d6), K101051 (d6), K141217 (d6), K061016 (d7), K090166 (d7), K080758 (d7), K073351 (d7), K092904 (d7), K083186 (d7), K120368 (d7), K003836 (d8), K010930 (d8), K033926 (d8), K094025 (d8), K103731 (d8) — cited as predicate by K191565, K191581, K192018, K192054

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — MEDTRONIC SOFAMOR DANEK, INC.

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