BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEWIN BONE HOLDING CLAMP, 7"

    MDR report key: 832130 · Received March 7, 2007

    Report

    Report Number
    2430952-2007-00009
    Event Type
    Malfunction
    Date Received
    March 7, 2007
    Date of Event
    January 23, 2007
    Report Date
    February 21, 2007
    Manufacturer
    HEBUMEDICAL GMBH
    Product Code
    HXD
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED DURING A HIP ARTHROPLASTY SURGERY, THE DEVICE'S HOLDER BROKE OFF. THE BROKEN TIP WAS LOCATED AND REMOVED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEWIN BONE HOLDING CLAMP, 7" ORTHOPEDICA SURGERY HXD HEBUMEDICAL GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR