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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

No recalls linked.

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
    2024-12-12NAINo action indicatedStryker Spine0
    2021-09-13NAINo action indicatedStryker Spine0
    2021-07-27NAINo action indicatedK2M, Inc.0
    2016-11-16VAIVoluntary action indicatedK2M, Inc.2
    2016-02-10NAINo action indicatedStryker Spine0
    2015-07-06NAINo action indicatedK2M, Inc.0
    2014-02-12NAINo action indicatedK2M, Inc.0
    2012-01-12NAINo action indicatedStryker Spine0
    2011-09-29VAIVoluntary action indicatedStryker Spine2
    2011-01-18VAIVoluntary action indicatedK2M, Inc.2
    2010-08-20NAINo action indicatedStryker Spine0
    2010-03-17VAIVoluntary action indicatedStryker Spine2
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