BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL BODY RETAINER

    MDR report key: 3081631 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11163
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    August 20, 2012
    Report Date
    August 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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 RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT DEVELOPMENT EVALUATION SHOWED THE VERTEBRAL BODY RETAINER IS FRACTURED ON BOTH SIDES OF THE FEMALE HINGE JOINT. THE BREAKAGE INDICATES EXCESSIVE FORCE WAS APPLIED TO THE INSTRUMENT. THE TWO SPOT WELD PAIR ON ONE SIDE OF THE PIN/HINGE INTERFACE ALSO FAILED. THERE IS SOME OXIDATION ON AND AROUND THE FRACTURED SURFACES. THIS OXIDATION MAY HAVE OCCURRED DUE TO THE EXPOSED METALLIC SURFACE DURING REPROCESSING. THE DESIGN WAS REVIEWED AND IS ADEQUATE WHEN USED AS INTENDED. BASED ON THE NUMBER OF 03.820.111 SOLD BETWEEN DECEMBER 2010 AND DECEMBER 2012, THE OCCURRENCE RATE OF BREAKAGES IS (B)(4) PERCENT. HOWEVER, AS THIS IS A MULTI USE INSTRUMENT, THE ACTUAL RATE OF OCCURRENCE OF BREAKAGES SHOULD BE SIGNIFICANTLY LOWER. IT SHOULD ALSO BE NOTED THAT THERE ARE COMPLAINTS CALCULATED INTO THE OCCURRENCE RATE ABOVE WHICH INVOLVE USING THIS DEVICE IN CASES OTHER THAN PRO DISC C AND MAY INVOLVE THE MISUSE OF THIS DEVICE AS A DISTRACTOR. (B)(4) COULD NOT LOCATE THE RISK ANALYSIS FOR THIS INSTRUMENT IN WINDCHILL. IN CONCLUSION, THE RETAINER WAS USED DURING A ZERO P CASE AND MAY HAVE BEEN USED AS A DISTRACTOR, MIS-USE. THIS INSTRUMENT IS MEANT TO BE USED AS A RETAINER AFTER DISTRACTION IN PRO DISC C CASES. IT IS NOT CLEAR HOW THIS INSTRUMENT WAS BEING USED FOR THIS FAILURE TO OCCUR. THEREFORE THIS COMPLAINT IS DEEMED INDETERMINATE.

    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. ORIGINAL AWARENESS DATE IS (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING AN ANTERIOR CERVICAL DECOMPRESSION FUSION, ZERO P PROCEDURE, THE ARM OF THE RETRACTOR BROKE OFF WHEN THE SURGEON RELEASED THE TENSION AND PULLED THE RETRACTOR BACK FROM THE STERILE FIELD. ALL PIECES OF THE RETRACTOR WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM AND NO ADVERSE EVENT TO THE PATIENT. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183500 VERTEBRAL BODY RETAINER LXH SYNTHES GMBH T924025

    Patients

    Seq Age Sex Outcome Treatment
    1