BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM 1.2 X 4MM

    MDR report key: 2860094 · Received November 21, 2012

    Report

    Report Number
    8010177-2012-00261
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 31, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HWC
    PMA / PMN Number
    K022185
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION. INTERNAL INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW HEAD SHEARED OFF WHILE SURGEON WAS INSERTING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM 1.2 X 4MM IMPLANT HWC STRYKER OSTEOSYNTHESIS FREIBURG NA UNKNOEN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK