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TRUMATCH

Model SD980.037 · Materialise NV · DI 05420060380877

DZJ — Driver, Wire, And Bone Drill, Manual · Class II · 21 CFR 872.4120

LLZ — System, Image Processing, Radiological · Class II · 21 CFR 892.2050

UDILibrary device dossier · generated 2026-09-11 · 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.

4812172019-01: 0 reports for this device; peer average 4.67/device2019-02: 0 reports for this device; peer average 9.4/device2019-03: 0 reports for this device; peer average 7.11/device2019-04: 0 reports for this device; peer average 6.8/device2019-05: 0 reports for this device; peer average 11/device2019-06: 0 reports for this device; peer average 8.82/device2019-07: 0 reports for this device; peer average 10.67/device2019-08: 0 reports for this device; peer average 15.7/device2019-09: 0 reports for this device; peer average 8.56/device2019-10: 0 reports for this device; peer average 5.44/device2019-11: 0 reports for this device; peer average 6.78/device2019-12: 0 reports for this device; peer average 10.33/device2020-01: 0 reports for this device; peer average 4.11/device2020-02: 0 reports for this device; peer average 8.23/device2020-03: 0 reports for this device; peer average 8.27/device2020-04: 0 reports for this device; peer average 9.77/device2020-05: 0 reports for this device; peer average 5.38/device2020-06: 0 reports for this device; peer average 2.45/device2020-07: 0 reports for this device; peer average 3.25/device2020-08: 0 reports for this device; peer average 3.06/device2020-09: 0 reports for this device; peer average 2.6/device2020-10: 0 reports for this device; peer average 3.1/device2020-11: 0 reports for this device; peer average 2.31/device2020-12: 0 reports for this device; peer average 3.42/device2021-01: 0 reports for this device; peer average 2.69/device2021-02: 0 reports for this device; peer average 2.82/device2021-03: 0 reports for this device; peer average 3.46/device2021-04: 0 reports for this device; peer average 3.18/device2021-05: 0 reports for this device; peer average 3.67/device2021-06: 0 reports for this device; peer average 3.32/device2021-07: 0 reports for this device; peer average 4.38/device2021-08: 0 reports for this device; peer average 3.8/device2021-09: 0 reports for this device; peer average 2.2/device2021-10: 0 reports for this device; peer average 2.88/device2021-11: 0 reports for this device; peer average 2.87/device2021-12: 0 reports for this device; peer average 4.08/device2022-01: 0 reports for this device; peer average 5/device2022-02: 0 reports for this device; peer average 2.5/device2022-03: 0 reports for this device; peer average 3/device2022-04: 0 reports for this device; peer average 2/device2022-05: 0 reports for this device; peer average 1.58/device2022-06: 0 reports for this device; peer average 3.5/device2022-07: 0 reports for this device; peer average 2.93/device2022-08: 0 reports for this device; peer average 3.15/device2022-09: 0 reports for this device; peer average 5/device2022-10: 0 reports for this device; peer average 3/device2022-11: 0 reports for this device; peer average 1.94/device2022-12: 0 reports for this device; peer average 2.14/device2023-01: 0 reports for this device; peer average 2.27/device2023-02: 0 reports for this device; peer average 2.27/device2023-03: 0 reports for this device; peer average 2.39/device2023-04: 0 reports for this device; peer average 2.14/device2023-05: 0 reports for this device; peer average 1.58/device2023-06: 0 reports for this device; peer average 2.79/device2023-07: 0 reports for this device; peer average 2.56/device2023-08: 0 reports for this device; peer average 2.11/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 3.58/device2023-11: 0 reports for this device; peer average 2.1/device2023-12: 0 reports for this device; peer average 1.87/device2024-01: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 2.76/device2024-03: 0 reports for this device; peer average 2.33/device2024-04: 0 reports for this device; peer average 4.53/device2024-05: 0 reports for this device; peer average 2.42/device2024-06: 0 reports for this device; peer average 2.44/device2024-07: 0 reports for this device; peer average 2.95/device2024-08: 0 reports for this device; peer average 3.22/device2024-09: 0 reports for this device; peer average 3.36/device2024-10: 0 reports for this device; peer average 3.09/device2024-11: 0 reports for this device; peer average 3.28/device2024-12: 0 reports for this device; peer average 2.28/device2025-01: 0 reports for this device; peer average 6.17/device2025-02: 0 reports for this device; peer average 6.5/device2025-03: 0 reports for this device; peer average 2.58/device2025-04: 0 reports for this device; peer average 2.36/device2025-05: 0 reports for this device; peer average 2.35/device2025-06: 0 reports for this device; peer average 2.8/device2025-07: 0 reports for this device; peer average 2.79/device2025-08: 0 reports for this device; peer average 3.78/device2025-09: 0 reports for this device; peer average 2.86/device2025-10: 0 reports for this device; peer average 9.4/device2025-11: 0 reports for this device; peer average 2.83/device2025-12: 0 reports for this device; peer average 6.03/device2026-01: 0 reports for this device; peer average 6.9/device2026-02: 0 reports for this device; peer average 3.84/device2026-03: 0 reports for this device; peer average 13.11/device2026-04: 0 reports for this device; peer average 11.4/device2026-05: 0 reports for this device; peer average 16.65/device2026-06: 0 reports for this device; peer average 9.38/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.67
2019-0209.4
2019-0307.11
2019-0406.8
2019-05011
2019-0608.82
2019-07010.67
2019-08015.7
2019-0908.56
2019-1005.44
2019-1106.78
2019-12010.33
2020-0104.11
2020-0208.23
2020-0308.27
2020-0409.77
2020-0505.38
2020-0602.45
2020-0703.25
2020-0803.06
2020-0902.6
2020-1003.1
2020-1102.31
2020-1203.42
2021-0102.69
2021-0202.82
2021-0303.46
2021-0403.18
2021-0503.67
2021-0603.32
2021-0704.38
2021-0803.8
2021-0902.2
2021-1002.88
2021-1102.87
2021-1204.08
2022-0105
2022-0202.5
2022-0303
2022-0402
2022-0501.58
2022-0603.5
2022-0702.93
2022-0803.15
2022-0905
2022-1003
2022-1101.94
2022-1202.14
2023-0102.27
2023-0202.27
2023-0302.39
2023-0402.14
2023-0501.58
2023-0602.79
2023-0702.56
2023-0802.11
2023-0902
2023-1003.58
2023-1102.1
2023-1201.87
2024-0102
2024-0202.76
2024-0302.33
2024-0404.53
2024-0502.42
2024-0602.44
2024-0702.95
2024-0803.22
2024-0903.36
2024-1003.09
2024-1103.28
2024-1202.28
2025-0106.17
2025-0206.5
2025-0302.58
2025-0402.36
2025-0502.35
2025-0602.8
2025-0702.79
2025-0803.78
2025-0902.86
2025-1009.4
2025-1102.83
2025-1206.03
2026-0106.9
2026-0203.84
2026-03013.11
2026-04011.4
2026-05016.65
2026-0609.38
This device (reports/month)Average device in DZJ, LLZ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K243637 — cites (transitively): K103136 (d1), K111558 (d1), K170272 (d1), K173039 (d1), K182789 (d1), K210731 (d1), K073449 (d2), K082358 (d2), K093533 (d2), K063790 (d2), K080331 (d2), K083388 (d2), K042365 (d2), K050608 (d2), K053199 (d2), K121574 (d2), K123723 (d2), K133809 (d2), K163579 (d2), K181241 (d2), K943347 (d2), K971297 (d2), K191028 (d2), K954385 (d3), K022012 (d3), K032442 (d3), K062570 (d3), K153482 (d3), K854886 (d3), K120956 (d3), K161634 (d3), K944565 (d3), K060950 (d4), K073468 (d4), K970617 (d4), K032413 (d4), K070169 (d4), K122860 (d4), K142823 (d4), K052424 (d4), K111641 (d4), K051165 (d5), K093772 (d5), K121302 (d5), K133616 (d5), K050041 (d6), K073556 (d6), K081623 (d6), K081700 (d6) — cited as predicate by K253308

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

Manufacturer compliance record — Materialise NV

Nothing in the loaded window.