BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER-LARGE

    MDR report key: 3081720 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11010
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    October 25, 2011
    Report Date
    October 25, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. HOWEVER, THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    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. (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN L5-S1 DISC ARTHROPLASTY, THE RAIL ON THE IMPLANT HOLDER BROKE AND WOULD NOT HOLD THE IMPLANT IN PLACE. SURGEON WAS ABLE TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185690 INSERTER-LARGE LXH SYNTHES GMBH A7 OA 27

    Patients

    Seq Age Sex Outcome Treatment
    1