BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFIX - LR TRIAL IMPL 12DEG

    MDR report key: 2982994 · Received February 26, 2013

    Report

    Report Number
    8030965-2013-10284
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Report Date
    June 6, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 (B)(4) 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING ANTERIOR LUMBAR FUSION L5-S1 PROCEDURE, THE SURGEON WAS INSERTING THE TRIAL SPACER WITH THE TRIAL SPACER HANDLE. THE TIP OF THE SPINDLE BROKE OFF IN THE SYNFIX LR TRIAL IMPLANT 12 DEG. THE SURGEON REMOVED THE TRAIL SPACER WITH CURETTES AND COMPLETED THE PROCEDURE. THIS COMPLAINT IS ON THE TRIAL SPACER HANDLE AND THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81234 SYNFIX - LR TRIAL IMPL 12DEG LXH SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1