BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE AL IMPLANT BLOCKER 12MM

    MDR report key: 2103308 · Received May 18, 2011

    Report

    Report Number
    9617544-2011-00177
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "AFTER THE KIT CAME BACK FROM THE HOSP UPON INSPECTION OF TRAY FOUND INSERT BLOCKER BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE AL IMPLANT BLOCKER 12MM INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 08D151

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK