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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
2016-02-18Z-1392-2016Class IITerminatedThe label on the outer packaging does not match the product inside and intended use of the device.Distribution: Distributed in the US: OH and ND6 unitsclearance family
Regulatory clearances

    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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