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VERTEX® Reconstruction System

Model 7755247 · MEDTRONIC SOFAMOR DANEK, INC. · DI 00613994245304

KWP — Appliance, Fixation, Spinal Interlaminal · Class II · 21 CFR 888.3050

UDILibrary device dossier · generated 2026-09-06 · 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.

23572019-01: 0 reports for this device; peer average 2.13/device2019-02: 0 reports for this device; peer average 1.87/device2019-03: 0 reports for this device; peer average 1.91/device2019-04: 0 reports for this device; peer average 1.98/device2019-05: 0 reports for this device; peer average 2.19/device2019-06: 0 reports for this device; peer average 2.19/device2019-07: 0 reports for this device; peer average 1.63/device2019-08: 0 reports for this device; peer average 2.5/device2019-09: 0 reports for this device; peer average 1.79/device2019-10: 0 reports for this device; peer average 1.85/device2019-11: 0 reports for this device; peer average 2.12/device2019-12: 0 reports for this device; peer average 1.54/device2020-01: 0 reports for this device; peer average 2.35/device2020-02: 0 reports for this device; peer average 2.32/device2020-03: 0 reports for this device; peer average 2.33/device2020-04: 0 reports for this device; peer average 1.45/device2020-05: 0 reports for this device; peer average 2.16/device2020-06: 0 reports for this device; peer average 1.93/device2020-07: 0 reports for this device; peer average 1.72/device2020-08: 0 reports for this device; peer average 1.83/device2020-09: 0 reports for this device; peer average 2.09/device2020-10: 0 reports for this device; peer average 2.38/device2020-11: 0 reports for this device; peer average 2.23/device2020-12: 0 reports for this device; peer average 2.07/device2021-01: 0 reports for this device; peer average 2.1/device2021-02: 0 reports for this device; peer average 1.83/device2021-03: 0 reports for this device; peer average 2.2/device2021-04: 0 reports for this device; peer average 2.05/device2021-05: 0 reports for this device; peer average 1.96/device2021-06: 0 reports for this device; peer average 1.88/device2021-07: 0 reports for this device; peer average 6.91/device2021-08: 0 reports for this device; peer average 1.89/device2021-09: 0 reports for this device; peer average 1.69/device2021-10: 0 reports for this device; peer average 2.28/device2021-11: 0 reports for this device; peer average 1.97/device2021-12: 0 reports for this device; peer average 1.97/device2022-01: 0 reports for this device; peer average 2.05/device2022-02: 0 reports for this device; peer average 1.91/device2022-03: 0 reports for this device; peer average 1.68/device2022-04: 0 reports for this device; peer average 1.78/device2022-05: 0 reports for this device; peer average 1.68/device2022-06: 0 reports for this device; peer average 1.95/device2022-07: 0 reports for this device; peer average 3.29/device2022-08: 0 reports for this device; peer average 1.88/device2022-09: 0 reports for this device; peer average 2.72/device2022-10: 0 reports for this device; peer average 1.43/device2022-11: 0 reports for this device; peer average 1.57/device2022-12: 0 reports for this device; peer average 1.94/device2023-01: 0 reports for this device; peer average 1.61/device2023-02: 0 reports for this device; peer average 1.78/device2023-03: 0 reports for this device; peer average 1.77/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 1.57/device2023-06: 0 reports for this device; peer average 1.64/device2023-07: 0 reports for this device; peer average 1.73/device2023-08: 0 reports for this device; peer average 1.34/device2023-09: 0 reports for this device; peer average 2.57/device2023-10: 0 reports for this device; peer average 2.44/device2023-11: 0 reports for this device; peer average 2.19/device2023-12: 0 reports for this device; peer average 1.63/device2024-01: 0 reports for this device; peer average 2.39/device2024-02: 0 reports for this device; peer average 2.14/device2024-03: 0 reports for this device; peer average 3.63/device2024-04: 0 reports for this device; peer average 1.73/device2024-05: 0 reports for this device; peer average 3.39/device2024-06: 0 reports for this device; peer average 2.23/device2024-07: 0 reports for this device; peer average 1.78/device2024-08: 0 reports for this device; peer average 1.79/device2024-09: 0 reports for this device; peer average 2.58/device2024-10: 0 reports for this device; peer average 2.27/device2024-11: 0 reports for this device; peer average 1.88/device2024-12: 0 reports for this device; peer average 1.76/device2025-01: 0 reports for this device; peer average 2.31/device2025-02: 0 reports for this device; peer average 2.45/device2025-03: 0 reports for this device; peer average 2.18/device2025-04: 0 reports for this device; peer average 2.25/device2025-05: 0 reports for this device; peer average 2.5/device2025-06: 0 reports for this device; peer average 2.29/device2025-07: 0 reports for this device; peer average 1.72/device2025-08: 0 reports for this device; peer average 1.96/device2025-09: 0 reports for this device; peer average 1.88/device2025-10: 0 reports for this device; peer average 1.93/device2025-11: 0 reports for this device; peer average 1.97/device2025-12: 0 reports for this device; peer average 2.27/device2026-01: 0 reports for this device; peer average 2.39/device2026-02: 0 reports for this device; peer average 2.4/device2026-03: 0 reports for this device; peer average 2.34/device2026-04: 0 reports for this device; peer average 1.83/device2026-05: 0 reports for this device; peer average 2.19/device2026-06: 0 reports for this device; peer average 4.25/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.13
2019-0201.87
2019-0301.91
2019-0401.98
2019-0502.19
2019-0602.19
2019-0701.63
2019-0802.5
2019-0901.79
2019-1001.85
2019-1102.12
2019-1201.54
2020-0102.35
2020-0202.32
2020-0302.33
2020-0401.45
2020-0502.16
2020-0601.93
2020-0701.72
2020-0801.83
2020-0902.09
2020-1002.38
2020-1102.23
2020-1202.07
2021-0102.1
2021-0201.83
2021-0302.2
2021-0402.05
2021-0501.96
2021-0601.88
2021-0706.91
2021-0801.89
2021-0901.69
2021-1002.28
2021-1101.97
2021-1201.97
2022-0102.05
2022-0201.91
2022-0301.68
2022-0401.78
2022-0501.68
2022-0601.95
2022-0703.29
2022-0801.88
2022-0902.72
2022-1001.43
2022-1101.57
2022-1201.94
2023-0101.61
2023-0201.78
2023-0301.77
2023-0402
2023-0501.57
2023-0601.64
2023-0701.73
2023-0801.34
2023-0902.57
2023-1002.44
2023-1102.19
2023-1201.63
2024-0102.39
2024-0202.14
2024-0303.63
2024-0401.73
2024-0503.39
2024-0602.23
2024-0701.78
2024-0801.79
2024-0902.58
2024-1002.27
2024-1101.88
2024-1201.76
2025-0102.31
2025-0202.45
2025-0302.18
2025-0402.25
2025-0502.5
2025-0602.29
2025-0701.72
2025-0801.96
2025-0901.88
2025-1001.93
2025-1101.97
2025-1202.27
2026-0102.39
2026-0202.4
2026-0302.34
2026-0401.83
2026-0502.19
2026-0604.25
This device (reports/month)Average device in KWP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K090714 — cited as predicate by K121191, K121877, K123656, K163375, K181350, K223764

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

Manufacturer compliance record — MEDTRONIC SOFAMOR DANEK, INC.

  • NAI 2026-02-06 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2017-10-26 Medtronic Sofamor Danek USA, Inc · 0 citations
  • VAI 2015-11-03 Medtronic Sofamor Danek USA Inc · 0 citations
  • VAI 2015-10-23 Medtronic Sofamor Danek USA Inc · 1 citations
  • VAI 2014-03-11 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2013-07-15 Medtronic Sofamor Danek USA, Inc · 0 citations
  • NAI 2013-07-15 Medtronic Sofamor Danek USA Inc · 0 citations
  • VAI 2012-06-06 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2011-02-23 Medtronic Sofamor Danek Usa Inc · 0 citations
  • VAI 2010-08-06 Medtronic Sofamor Danek USA Inc · 0 citations
  • VAI 2010-03-04 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2010-02-25 Medtronic Sofamor Danek USA Inc · 0 citations