BEUDAMED
    FDA Adverse Event Other Summary report: N

    TWIST DRILL FOR 6 MM SCRES, CIAM. 1.0 X 50 MM, WL 7MM

    MDR report key: 2214135 · Received July 22, 2011

    Report

    Report Number
    8010177-2011-00208
    Event Type
    Other
    Date Received
    July 22, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 30, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HBE
    PMA / PMN Number
    K070876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    AN EXPIRED DRILL BIT WAS USED DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWIST DRILL FOR 6 MM SCRES, CIAM. 1.0 X 50 MM, WL 7MM IMPLANT HBE STRYKER OSTEOSYNTHESIS FREIBURG NA G5A01F8R06

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK