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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
2019-09-16Z-0223-2020Class IITerminatedThe subject product measures 4.0mm in diameter instead of 3.5mm.Distribution: Distributed to NJ.6clearance family
Regulatory clearances
  • 510(k)K142838Substantially equivalent (SESE) · 2015-01-20clearance family
  • 510(k)K141897Substantially equivalent (SESE) · 2014-09-25clearance family

Predicate lineage

K090549

Cited as predicate by: K181350

K091689

Cited as predicate by: K133556, K141897, K142460, K171250

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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