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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
2025-06-24Z-2555-2025Class IIOpen, ClassifiedA 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.Distribution: US Nationwide distribution in the states of CO, CA.3code info di
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
    2023-03-17VAIVoluntary action indicatedOrthofix U.S. LLC2
    2012-09-27VAIVoluntary action indicatedOrthofix Srl1
    2012-09-27VAIVoluntary action indicatedOrthofix Srl1
    2011-06-24VAIVoluntary action indicatedOrthofix U.S. LLC1
    2010-02-23NAINo action indicatedOrthofix U.S. LLC0
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