BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT HOLDER FOR SYNFIX(TM)-LR

    MDR report key: 3070702 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10955
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    November 28, 2011
    Report Date
    November 28, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED NO VISIBLE DAMAGES. THE IMPLANT AND IMPLANT HOLDER WHICH ARE THE SUBJECT OF THIS COMPLAINT WERE RETURNED ALREADY DISASSEMBLED. THE DEVICE PASSED THE REQUIRED FUNCTIONAL TEST SUCCESSFULLY. IT IS POSSIBLE TO ENGAGE AND DISENGAGE CORRECTLY OTHER IMPLANTS. THE MICROSCOPIC INVESTIGATION SHOWS ROUNDED THREAD FLANKS AND WEAR ON THE THREAD RUN-IN. THE DEVICE MET FULLY TO THE SPECIFICATIONS AT THE TIME OF DISTRIBUTING. THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING STANDPOINT. 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. ADDITIONAL NARRATIVE: THE PRODUCT DEVELOPMENT EVALUATION REPORTED THE IMPLANT AND IMPLANT HOLDER WHICH ARE THE SUBJECT OF THIS COMPLAINT WERE RETURNED ALREADY DISASSEMBLED. THE FAILURE WAS ATTEMPTED TO BE RECREATED USING THE RETURNED PARTS, BUT THEY WERE NO LONGER CAPABLE OF BEING FULLY ASSEMBLED. THE IMPLANT THREADS ARE DAMAGED AND APPEAR CROSS THREADED, PREVENTING IT FROM MATING PROPERLY WITH THE RETURNED IMPLANT HOLDER AND OTHER IMPLANT HOLDERS IN-HOUSE. THE RETURNED IMPLANT HOLDER WAS ABLE TO ENGAGE AND DISENGAGE CORRECTLY OFF OTHER IMPLANTS IN-HOUSE, INDICATING IT WAS FUNCTIONING PROPERLY. BASED ON THE EVALUATION OF THE RETURNED PARTS, IT IS LIKELY THAT THE IMPLANT HOLDER WAS CROSS THREADED ONTO THE IMPLANT, MAKING IT DIFFICULT TO DISENGAGE. HOWEVER, SINCE RETURNED IMPLANT WAS REMOVED FROM THE INSTRUMENT PRIOR TO THIS PD EVALUATION, IT IS DIFFICULT TO ASSESS THE ASSEMBLED CONDITION OF THE TWO COMPONENTS. THE COMPLAINT IS DEEMED INDETERMINATE. (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ALIF AT L5-S1, SURGEON PLACED THE IMPLANT IN THE CORRECT POSITION THEN HE COULD NOT DISENGAGE INSERTER FROM THE IMPLANT. SURGEON REMOVED INSERTER AND IMPLANT FROM PATIENT. SURGEON USED ANOTHER INSERTER AND IMPLANT AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    PROCEDURE WAS REPORTED TO BE ANTERIOR LUMBAR INTERBODY FUSION (ALIF) AT L5-S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172775 IMPLANT HOLDER FOR SYNFIX(TM)-LR LXH SYNTHES GMBH 2240703

    Patients

    Seq Age Sex Outcome Treatment
    1