BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 3191532 · Received June 26, 2013

    Report

    Report Number
    1719045-2013-01614
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    July 19, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. SUBJECT DEVICE WAS RECEIVED AND EVALUATED. NO DEVICE DEFECTS WERE DETECTED. THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO INDICATIONS THAT ANYTHING IN THE MANUFACTURING PROCESS CONTRIBUTED TO THE EVENT.

    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.DEVICE MANUFACTURE DATE WAS BETWEEN 5/8/09 AND 6/8/09.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TENSIONER, PART NUMBER 391.201, WAS UNABLE TO FUNCTION IN THAT THE CABLE TENSION COULD NOT BE INCREASED AND THE CABLE SNAPPED DURING USE. THERE WAS NO REPORTED ILL EFFECT ON THE PATIENT OR INCREASE IN SURGERY TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290055 CABLE TENSIONER LXH SYNTHES MONUMENT P049358

    Patients

    Seq Age Sex Outcome Treatment
    1