BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-CLIP PLATE SPREADER

    MDR report key: 970048 · Received December 27, 2007

    Report

    Report Number
    9615741-2007-00078
    Event Type
    Malfunction
    Date Received
    December 27, 2007
    Report Date
    December 26, 2007
    Manufacturer
    NEWDEAL S.A.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE INTEGRA SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THE FOLLOWING INCIDENT: DURING A UNI-CLIP PLACEMENT, THE DOCTOR WAS USING THE SPREADER TO SPREAD THE UNI-CP STABLE AND ONE OF THE TEETH BROKE. NO EXTENSION OF SURGERY TIME OCCURRED, AND THE PT WAS NOT INJURED. THE DEVICE IS AVAILABLE FOR RETURN AND HAS BEEN REQUESTED BY INTEGRA LIFESCIENCES CORP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNI-CLIP PLATE SPREADER UNI-CLIP INSTRUMENT LXH NEWDEAL S.A. E6WS

    Patients

    Seq Age Sex Outcome Treatment
    1 YR