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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
2018-12-10Z-0833-2019Class IITerminatedProduct mix upDistribution: US Nationwide Distribution in the states of FL, NY, and TN10code info di
Regulatory clearances

    Predicate lineage

    K170613

    Cited as predicate by: K190577

    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
    2018-07-05VAIVoluntary action indicatedSignature Orthopedics Pty Limited3
    2013-06-27VAIVoluntary action indicatedSignature Orthopedics Pty Limited1
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