BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW, T7 DIAM.2.7X14MM

    MDR report key: 3982489 · Received August 6, 2014

    Report

    Report Number
    0008010177-2014-00199
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 10, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K080667
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    VARIAX DISTAL RADIUS SCREW HEAD STRIPPING. REP REPORTED THAT EVENT RESOLVED BY "SCREW REMOVED AND REPLACED." HAD TO USE SCREW REMOVAL SET TO GET SCREW OUT SURGICAL DELAY APPROX. 60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461279 LOCKING SCREW, T7 DIAM.2.7X14MM PLATE, FIXATION, BONE HRS STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention