BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOURED CROSSBAR LARGE 3.5 ROD

    MDR report key: 3101351 · Received May 3, 2013

    Report

    Report Number
    2032593-2013-00027
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 3, 2013
    Manufacturer
    SEASPINE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K080526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER NOTED: "THE SURGEON WAS TIGHTENING DOWN THE SCREW IN THE CROSSBAR (50-2013), WHEN SCREW APPEARED TO STRIP UNABLE TO REMOVE, LEFT IN PATIENT. SURGERY WAS ALREADY AT ITS COMPLETION, STRIPPED SCREW WAS LEFT IN PATIENT, DID NOT HEAR THE AUDIBLE SNAP BUT APPEARED TO BE SEATED." ADDITIONAL INFORMATION WAS REQUESTED BY INTEGRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195495 CONTOURED CROSSBAR LARGE 3.5 ROD SIERRA KWP SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 CROSSBAR DRIVER (95-0109)