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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.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2025-05-01Z-2172-2025Class IIOpen, ClassifiedThe Drill stop kit contains incorrect components.Distribution: Worldwide - US Nationwide distribution in the states of AL, FL, LA, MD, NJ, NV, NY, OH, OK, TN, TX, UT, VA and the country of Japan.45 Kitsclearance family
Regulatory clearances
  • 510(k)K200858Substantially equivalent (SESE) · 2020-08-06clearance family

Predicate lineage

Cited as predicate by: K202524

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
2021-05-12VAIVoluntary action indicatedImplant Direct Sybron Manufacturing LLC1
2019-12-02OAIOfficial action indicatedImplant Direct Sybron Manufacturing LLC5
2015-04-21NAINo action indicatedImplant Direct Sybron Manufacturing LLC0
2014-04-03NAINo action indicatedImplant Direct Sybron Manufacturing LLC0
2012-02-10NAINo action indicatedImplant Direct Sybron Manufacturing LLC0
2011-08-16NAINo action indicatedImplant Direct Sybron Manufacturing LLC0
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