BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME GUIDE ROD

    MDR report key: 3070376 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10933
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    December 9, 2011
    Report Date
    December 13, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR A MANUFACTURING EVALUATION AND THE CLAMPING JAWS WERE CRACKED, WITH VISIBLE DEFORMATION ON THE LOCKING SCREWS. MICROSCOPIC INVESTIGATION SHOWED THAT THE DEVICES WERE MANY TIMES OVER-TIGHTENED DURING USE, WHICH LED TO FATIGUE BREAKAGES OF THE CLAMPING JAWS AND DEFORMATION OF THE LOCKING SCREWS. THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING STANDPOINT.

    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. ORIGINAL AWARENESS DATE IS 12/13/2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE, AS THE SURGEON TIGHTENED THE SCREWS, THE SCREWS STRIPPED AND WOULD NOT SEAT OR TIGHTEN THE SYNFRAME GUIDE ROD. THE SURGEON USED ANOTHER SYNFRAME SYSTEM AND COMPLETED THE PROCEDURE. NOTHING WAS BROKEN INTO THE WOUND, NOTHING TO RETRIEVE. THIS IS REPORT 1 OF 3 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172214 SYNFRAME GUIDE ROD LXH SYNTHES GMBH 2722430

    Patients

    Seq Age Sex Outcome Treatment
    1