BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS, CROSS PIN, SELF-TAPPING, DIAM 1.2X4MM

    MDR report key: 2871705 · Received December 11, 2012

    Report

    Report Number
    8010177-2012-00280
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    SURGEON WAS INSERTING A SCREW INTO THE ORBITAL RIM, AND THE HEAD DISASSEMBLED FROM REST OF THE SCREW. THE SURGEON WAS ABLE TO REMOVE THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREWS, CROSS PIN, SELF-TAPPING, DIAM 1.2X4MM IMPLANT HWC STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK