BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL INSTRUMENT ELEVATOR

    MDR report key: 33894 · Received July 3, 1996

    Report

    Report Number
    MW1009426
    Event Type
    Malfunction
    Date Received
    July 3, 1996
    Date of Event
    May 11, 1996
    Report Date
    June 26, 1996
    Manufacturer
    V. MUELLER DIV. BAXTER HEALTHCARE CORP.
    Product Code
    GEG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING ORTHOPEDIC/SURGICAL REPAIR OF FRACTURED TIBIA, THE TIP OF THE ELEVATOR BROKE OFF IN WOUND. IT WAS THEN LOCATED UNDER FLUOROSCOPY AND THE TIP WAS RETRIEVED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL INSTRUMENT ELEVATOR SURGICAL INSTRUMENT ELEVATOR GEG V. MUELLER DIV. BAXTER HEALTHCARE CORP. RH750

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR