BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME GUIDE ROD

    MDR report key: 3071391 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-11026
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    July 17, 2012
    Report Date
    July 18, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION, SO NO EVALUATION COULD BE CONDUCTED AND CONCLUSION COULD BE DRAWN. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR LUMBAR PROCEDURE, TWO SYNFRAME GUIDE RODS BROKE AS THE SURGEON WAS TIGHTENING THE SYNFRAME. THERE WAS NO HARM TO THE PATIENT OR THE SURGEON, AND THE PROCEDURE WAS NOT SIGNIFICANTLY EXTENDED IN LENGTH. THIS REPORT IS 2 OF 2 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173067 SYNFRAME GUIDE ROD LXH SYNTHES GMBH 2777242

    Patients

    Seq Age Sex Outcome Treatment
    1