BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREPHINE, 12MM DIAMETER

    MDR report key: 1844642 · Received September 22, 2010

    Report

    Report Number
    8010177-2010-00332
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HWK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT RETURNED. INTERNAL INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    PER SALES REP: DURING A CASE USING THE GBAT SYSTEM, THE TREPHINE SEVERED THE MUSCLE OF THE PT. THE MUSCLE WAS REPAIRED WITH SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREPHINE, 12MM DIAMETER IMPLANT HWK STRYKER OSTEOSYNTHESIS FREIBURG NA 0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention