BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRILL F.10-20MM SCREWS,SAGI.SP

    MDR report key: 1329193 · Received March 2, 2009

    Report

    Report Number
    8010177-2009-00018
    Event Type
    Other
    Date Received
    March 2, 2009
    Date of Event
    June 18, 2007
    Report Date
    January 29, 2009
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HBE
    PMA / PMN Number
    K070876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE NOT EVALUATED BECAUSE THE DEVICE IS NOT AVAILABLE TO STRYKER. EVALUATION WILL BE CONDUCTED AND REPORTED IN THE FOLLOW UP.

    Description of Event or Problem · 1

    APPROXIMATELY 1.5 YEARS AGO, A GIRL BURNED HER CHEEK WHILE SURGEON WAS USING PART NUMBER 60-19820. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL F.10-20MM SCREWS,SAGI.SP INSTRUMENT HBE STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK