BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX DISTRACTOR RACK

    MDR report key: 3003616 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10418
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. MANUFACTURING EVALUATION REPORTS THE SAMPLE WAS RECEIVED WITH THE SCREW BROKEN OFF THE WING NUT. INSTRUMENT CORRESPONDS TO DRAWINGS AND PROCESSES AT TIME OF MANUFACTURE. OVER TIGHTENING ASSEMBLY CAN POSSIBLY LEAD TO BREAKAGE. THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING PERSPECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LUMBAR FUSION L3-L5, THE SCREW AND NUT THAT RETAINS THE KNOB ON THE MATRIX DISTRACTOR BROKE. THE BROKEN PIECES WERE RETRIEVED. SURGEON USED SECOND SET TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88081 MATRIX DISTRACTOR RACK LXH SYNTHES GMBH T958361

    Patients

    Seq Age Sex Outcome Treatment
    1