BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM. 1.2X6MM

    MDR report key: 2172328 · Received June 23, 2011

    Report

    Report Number
    8010177-2011-00182
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    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 PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    WHEN INSERTING A SCREW, THE HEAD OF THE SCREW STAYED ATTACHED TO THE SCREWDRIVER BLADE AND DISCONNECTED FROM THE REST OF THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM. 1.2X6MM IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK