BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_FRO_PRODUCT

    MDR report key: 3830578 · Received May 23, 2014

    Report

    Report Number
    0008010177-2014-00134
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    WHILE TRYING TO FIXATE A BSSO, THE HEADS OF 3 SELF TAPPING SCREWS DETACHED. WHILE DRILLING THE FINAL SCREW, THE RAINBOW DRILL BIT WORKING IN DETACHED. DUE TO UNSATISFACTORY OCCLUSION, THE SCREWS WERE REMOVED AND 2.0/2.3 MANDIBLE SCREW WERE USED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308184 UNKNOWN_FRO_PRODUCT IMPLANT JEY STRYKER LEIBINGER FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR