BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCT-INSTR F/SPONDYLOLISTH STD F/MATRI

    MDR report key: 3183580 · Received June 22, 2013

    Report

    Report Number
    2520274-2013-03448
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Date of Event
    June 11, 2012
    Report Date
    June 12, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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 WHILE USING A MATRIX REDUCTION SPONDYLOLITHESIS TOOL, THE TIP OF THE INSTRUMENT BROKE OFF. THE TIPS ON THE BLACK PLASTIC NUT WERE SNAPPED OFF. ALL TIPS WERE ACCOUNTED FOR. IT IS BELIEVED THAT THE TOOL WAS FORCEFULLY ASSEMBLED BY THE SCRUB NURSE CAUSING THE TIPS TO BREAK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284087 REDUCT-INSTR F/SPONDYLOLISTH STD F/MATRI LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1