BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEWIN BONE HOLDING CLAMP, 7"

    MDR report key: 1182663 · Received September 25, 2008

    Report

    Report Number
    2430952-2008-00026
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Report Date
    September 25, 2008
    Product Code
    HXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. INTEGRA LIFESCIENCES CORPORATION IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR. CORRESPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORPORATION.

    Description of Event or Problem · 1

    A MEDWATCH REPORT WAS RECEIVED FROM THE HOSPITAL ON 9/11/08 WHICH INDICATED A 225-175 BONE CLAMP WAS BROKEN DURING HIP SURGERY. THERE WAS NO HARM TO THE PATIENT, AND THE BROKEN PIECE(S) WERE RETRIEVE. AN X-RAY WAS TAKEN WHICH CONFIRMED THERE WERE NO PIECES OF THE INSTRUMENT LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEWIN BONE HOLDING CLAMP, 7" JARIT ORTHOPEDIC SURGERY HXD

    Patients

    Seq Age Sex Outcome Treatment
    1