BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT HOLDER, FOR SYNFIX-LR

    MDR report key: 2994010 · Received February 27, 2013

    Report

    Report Number
    8030965-2013-10251
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    UPON IMPACTION DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURE AT L4-L5, THE TAB ON THE IMPLANT HOLDER BROKE OFF INTO THE SYNFIX-LR. THE GRAFT WAS REMOVED AND REPLACED WITH ANOTHER GRAFT. AN ADDITIONAL 15 MINUTES WAS ADDED TO THE PROCEDURE. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83790 IMPLANT HOLDER, FOR SYNFIX-LR LXH SYNTHES GMBH 2468931

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention