BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPORARY DISTRACTION PEG

    MDR report key: 2945163 · Received February 1, 2013

    Report

    Report Number
    1719045-2013-10009
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    SYNTHES (USA) MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE (S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE SAMPLE WAS DISCARDED BY THE USER FACILITY. THE LOT NUMBER IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS THE SAMPLE WAS NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VEPTR EXPANSION PROCEDURE THE TIP OF THE TEMPORARY DISTRACTION PEG BROKE OFF. ALL PIECES WERE RETRIEVED FROM THE PT. THE PT WAS UNHARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43782 TEMPORARY DISTRACTION PEG LXH SYNTHES (USA) MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1