BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT HOLDER FOR SYNFIX(TM)-LR

    MDR report key: 3031820 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-10696
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    May 23, 2012
    Report Date
    May 23, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. ORIGINAL AWARENESS DATE IS (B)(4) /2012. ADDITIONAL INFORMATION WAS RECEIVED (B)(4) 2013. PLACEHOLDER.

    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. PRODUCT DEVELOPMENT EVENT EVALUATION REPORTS THAT THE SAMPLE WAS RECEIVED BROKEN AT THE INTERNAL THREADED SHAFT. THIS ISSUE WAS PREVIOUSLY EVALUATED AND DEEMED INDETERMINATE. ACCORDING TO PREVIOUS EVALUATION, THE FAILURE IS LIKELY NOT DUE TO EXCESSIVE LOADING OF A PROPERLY ATTACHED INSTRUMENT. THIS CONCLUSION IS BASED ON PREVIOUS STATIC TESTING AND CADAVER LAB EVALUATION. THE INSTRUMENT PERFORMS AS DESIGNED WHEN USED ACCORDING TO IT LABELING. IF THE INSTRUMENT IS NOT ATTACHED COMPLETELY, THE STATIC MOMENT TO FAILURE DROPS. A POTENTIAL CAUSE OF INTRA-OPERATIVE FAILURE IS CROSS-THREADING THE INSTRUMENT TO THE IMPLANT, DAMAGING AND THEREBY WEAKENING THE THREAD POST MAKING IT SUSCEPTIBLE TO FRACTURE UNDER NORMAL STATIC AND IMPACTION LOADS. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR LUMBER INTERBODY FUSION (ALIF) PROCEDURE AT L5-S1, THE THREADED TIP OF THE IMPLANT HOLDER BROKE OFF INSIDE THE IMPLANT WHILE THE SURGEON WAS TRYING TO REPOSITION THE IMPLANT. THE SURGEON USED ANOTHER HOLDER AND IMPLANT AND COMPLETED THE PROCEDURE. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS REPORT IS FOR FILE (B)(4). PER FOLLOW UP INFORMATION, THERE WAS NO TIME DELAY DUE TO THE INCIDENT, NO REOPERATION, AND NO PIECES OF THE DEVICE REMAINED IN THE PATIENT AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134461 IMPLANT HOLDER FOR SYNFIX(TM)-LR LXH SYNTHES GMBH 2707985

    Patients

    Seq Age Sex Outcome Treatment
    1