BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONES SCREWS, CROSS-PIN, SELF-TAPPING, DIAM. 1.2X4MM

    MDR report key: 1960351 · Received December 16, 2010

    Report

    Report Number
    8010177-2010-00467
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 23, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    PER SALES REP, THE SURGEON WAS TIGHTENING THE SCREW AND THE HEAD SNAPPED OFF. THE SURGEON FIXATED ANOTHER POINT ON THE PLATE AND LEFT THE THREAD IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONES SCREWS, CROSS-PIN, SELF-TAPPING, DIAM. 1.2X4MM IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK