BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM BONE SCREWS, DIAM.2.7X16MM, CROSS-PIN, SELF-TAPPING, (5/PACKAGE)

    MDR report key: 3201001 · Received July 2, 2013

    Report

    Report Number
    0008010177-2013-00141
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 31, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K961496
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT FOLLOWING THE IMPLANT OF A DISTAL RADIUS PLATE MATRIX, THE IMPLANT WAS TORN CAUSING BREAKAGE OF A SCREW. A SCREW STAYED INTO THE BONE AND CROSSED THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301686 TITANIUM BONE SCREWS, DIAM.2.7X16MM, CROSS-PIN, SELF-TAPPING, (5/PACKAGE) IMPLANT HRS STRYKER OSTEOSYNTHESIS-FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1