BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR C 7MM INSERTER

    MDR report key: 2833532 · Received October 29, 2012

    Report

    Report Number
    9617544-2012-00465
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    ODP
    PMA / PMN Number
    K102606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION 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 EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "CHECKED INSERTERS AFTER SET WAS RETURNED FROM SURGERY (SURGERY ON THURSDAY (B)(6) 2012 WITH DR (B)(6)). THE 7 MM INSERTER IS NOT THREADING INTO IMPLANT PROPERLY. I CHECKED WITH THE REP, AND THERE WERE NO PROBLEMS DURING SURGERY WITH DR (B)(6)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR C 7MM INSERTER INSTRUMENT ODP STRYKER SPINE BORDEAUX NA 11D002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK