BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX THREADED PERSUADER

    MDR report key: 3003383 · Received February 28, 2013

    Report

    Report Number
    2530088-2013-10209
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    SYNTHES (USA) MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POSTERIOR LUMBAR INTERBODY FUSION, THE BLACK THREADED PORTION OF THE MATRIX THREADED PERSUADER BROKE OFF DURING REDUCTION. ALL PIECES WERE RETRIEVED AND PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86940 MATRIX THREADED PERSUADER LXH SYNTHES (USA) MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1