BEUDAMED
    FDA Adverse Event Summary report: N

    BONE REDUCTION FORCEPS, 5 1/2", CURVED

    MDR report key: 511094 · Received February 11, 2004

    Report

    Report Number
    2430952-2004-00005
    Date Received
    February 11, 2004
    Date of Event
    December 18, 2003
    Report Date
    February 11, 2004
    Manufacturer
    KARL LEIBINGER GMBH & CO
    Product Code
    GEN
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE INSTRUMENT WAS RETURNED FOR REPAIR IN JANUARY 2004. THE PAPERWORK WHICH ACCOMPANIED THE INSTRUMENT INDICATED THE INSTRUMENT BROKE DURING A SURGICAL PROCEDURE IN 2003. TWO HOURS INTO THE SURGICAL PROCEDURE THE JAW PART BROKE OFF WHILE TIGHTENING ON BONE. NO PT INJURY WAS REPORTED BUT THE REPORTER DID INDICATE "COULD HAVE CAUSED AN INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE REDUCTION FORCEPS, 5 1/2", CURVED FORCEPS GEN KARL LEIBINGER GMBH & CO * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN