BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEWIN BONE HOLDING CLAMP, 7"

    MDR report key: 888833 · Received July 26, 2007

    Report

    Report Number
    2430952-2007-00022
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Report Date
    June 20, 2007
    Manufacturer
    HEBUMEDICAL GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY STATED THE INSTRUMENT WAS USED DURING A TOTAL JOINT REPLACEMENT PROCEDURE. THE TIP OF THE INSTRUMENT BROKE OFF DURING USE. NO PATIENT INJURY IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEWIN BONE HOLDING CLAMP, 7" ORTHOPEDIC SURGICAL INSTRUMENT LXH HEBUMEDICAL GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *