BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SR90D RATCHING CAP REMV/I

    MDR report key: 2848416 · Received November 21, 2012

    Report

    Report Number
    9617544-2012-00518
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 24, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SRDS REMOVAL TOOLS ORDERED FOR HARDWARE REMOVAL. REMOVAL TOOL FAILED. ONLY RATCHETED HALF WAY. SURGEON TRIED OTHER METHODS BUT FAILED. ABORTED SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SR90D RATCHING CAP REMV/I INSTRUMENT LXH STRYKER SPINE BORDEAUX NA G0B0615

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R