BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEWIN BONE HOLD CLAMP 7

    MDR report key: 3130142 · Received May 21, 2013

    Report

    Report Number
    2523190-2013-00023
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 21, 2013
    Manufacturer
    INTEGRA YORK, PA INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    FORCEPS BROKE WHILE DR (B)(6) WAS GRASPING FEMORAL HEAD. NO PT INJURY PER CUSTOMER. THERE WAS ONLY A POSSIBLE 10 SECOND DELAY IN PROCEDURE. CUSTOMER REPORTS ONE OF THE PRONGS BROKE OFF. ROUTINE X-RAY TAKEN AFTER PROCEDURE AND NO PARTS LEFT IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225362 LEWIN BONE HOLD CLAMP 7 NA LXH INTEGRA YORK, PA INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR