BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.5X4

    MDR report key: 1850326 · Received September 22, 2010

    Report

    Report Number
    8010177-2010-00336
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K031659
    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: SURGEON WAS SCREWING THE BONE SCREW INTO THE FLAP AND THE HEAD SHEARED OFF. SHAFT WAS LEFT IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURO SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.5X4 IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK