BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN-LINE NH 5MM LEFT-CURVE

    MDR report key: 1432684 · Received May 11, 2009

    Report

    Report Number
    2430952-2009-00007
    Event Type
    Malfunction
    Date Received
    May 11, 2009
    Report Date
    May 11, 2009
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO. INTEGRA LIFESCIENCES CORPORATION IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR (B)(4). CORRESPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORPORATION, (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE JAW WAS BROKEN ON TWO NEEDLE HOLDERS. ONE JAW OF ONE OF THE RETURNED NEEDLE HOLDERS WAS BROKEN IN THE PT DURING A LAPAROSCOPIC PROCEDURE AND WAS REMOVED FROM THE PT. THE OR DISPOSED OF THE BROKEN PIECE, SO NOT RETURNED. AN X-RAY WAS TAKEN, AND IT WAS REPORTED THAT NO PARTS REMAINED IN THE PT. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IN-LINE NH 5MM LEFT-CURVE NA LXH

    Patients

    Seq Age Sex Outcome Treatment
    1