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Adverse-event reports (MAUDE)

Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

4 linked reportsInjury 4
12342019-01: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2020-08: 4 reports for this device; peer average 4.25/device2020-11: 0 reports for this device; peer average 3/device2021-02: 0 reports for this device; peer average 1.5/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1.6/device2025-10: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 1/device0103050611120102050811020304050711030607040710100206
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0301
2019-0501
2019-0601
2019-1101
2019-1201
2020-0102
2020-0201
2020-0501
2020-0844.25
2020-1103
2021-0201.5
2021-0302
2021-0401
2021-0502
2021-0703
2021-1102
2022-0301
2022-0601
2023-0701
2024-0401
2024-0701
2024-1001.6
2025-1001
2026-0202
2026-0601
This device (reports/month)Average device in GXP (reports/device/month)
Failure-mode summaryAI-generated

4 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2020-08-182939274-2020-03600InjuryAvailableexact di
2020-08-142939274-2020-03542InjuryAvailableexact di
2020-08-112939274-2020-03464InjuryAvailableexact di
2020-08-072939274-2020-03427InjuryAvailableexact di
Regulatory clearances
  • 510(k)K102018Substantially equivalent (SESE) · 2010-09-23clearance family

Predicate lineage

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2017-08-08NAINo action indicatedSynthes GmbH0
2017-01-18NAINo action indicatedSynthes (USA), LLC0
2015-05-08VAIVoluntary action indicatedSynthes (USA), LLC2
2013-11-13VAIVoluntary action indicatedSynthes, Inc.1
2013-05-16NAINo action indicatedSynthes, Inc.0
2012-10-19VAIVoluntary action indicatedSynthes, Inc.1
2012-02-16WLWarning LetterSynthes, Inc.—
2012-02-01NAINo action indicatedSynthes (USA), LLC0
2011-09-15OAIOfficial action indicatedSynthes, Inc.10
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