BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.2MM TI CLICK X PEDICLE SCR PREASSEMBLED 40MM THRD LENGTH

    MDR report key: 3070362 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10920
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    December 13, 2011
    Report Date
    December 13, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED FOR A MANUFACTURING EVALUATION AND ONE FLANGE OF THE CLICK X HEAD WAS BENT OUTWARD. THE THREAD FLANKS OF THE LOCKING CAP THREAD WERE WORN OUT, SLIGHTLY DEFORMED, AND HAD A BURR. THE RELEVANT DIMENSIONS COULD NOT BE VERIFIED BECAUSE OF THE DAMAGES. THE BLUE ANODIZATION LAYER WAS WORN AWAY AT THE THREAD FLANKS WHICH IS A CLEAR INDICATION THAT THE DAMAGE WAS CAUSED POST-MANUFACTURING BY HIGH FORCES. THIS AND THE BENT FLANGE INDICATE THAT IMPROPER ALIGNMENT OF THE LOCKING CAP DURING TIGHTENING MAY HAVE CAUSED THE EVENT. HOWEVER, BECAUSE ALL DIMENSIONS COULD NOT BE VERIFIED, THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. A PRODUCT DEVELOPMENT EVALUATION WAS ALSO PERFORMED. MANY OF THE DEVICES INVOLVED IN THIS COMPLAINT EVENT WERE NOT RETURNED FOR EVALUATION AND THE TECHNIQUE THAT WAS BEING USED DURING THE PROCEDURE IS UNKNOWN. THE DAMAGE TO THE INTERNAL THREADS SUGGESTS THAT THE SPLAYING MAY HAVE BEEN CAUSED BY A MISALIGNED LOCKING CAP THAT WAS FORCIBLY TURNED INTO THE HEAD OF THE SCREW. A SPLAYED HEAD WILL NOT RETAIN THE INNER SLEEVE COMPONENT PROPERLY, AND THIS EXPLAINS THE DISASSEMBLED STATE OF THE IMPLANT. IN THE PROVIDED DISASSEMBLED AND DAMAGED CONDITION IT IS NOT POSSIBLE TO ATTEMPT TO RECREATE THE EVENT. THERE IS NO APPARENT INDICATION THAT THERE IS A DESIGN-RELATED ISSUE WITH THIS IMPLANT. THEREFORE, THIS COMPLAINT IS INVALID FROM A DESIGN STANDPOINT.

    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.

    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. IMPLANT DATE WAS IN 2008, EXACT DATE UNKNOWN. EXPLANT DATE IS (B)(6) 2011. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT APPROXIMATELY 3 YEARS STATUS POST A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE L3-L5 RETURNED FOR REOPERATION TO TREAT A CHRONIC HERNIATED DISC AT S1. AS THE SURGEON WAS INSERTING HARDWARE FOR THE REVISION, THE HEAD OF THE S1 SCREW SPLAYED AS IT WAS BEING TIGHTENED. THE SURGEON REMOVED AND REPLACED THE SAME ROD, 2 SAME CAPS AND THEN REINSERTED A NEW SCREW. THERE WERE NO FURTHER PROBLEMS AND THE PROCEDURE WAS COMPLETED. THIS REPORT IS FOR (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171968 6.2MM TI CLICK X PEDICLE SCR PREASSEMBLED 40MM THRD LENGTH NKB SYNTHES GMBH 3393268

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR