BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIF TRIAL SPACER-QUICK RELEASE 11MM HEIGHT

    MDR report key: 5250308 · Received November 25, 2015

    Report

    Report Number
    1719045-2015-10773
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Report Date
    November 9, 2015
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HWT
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A SERVICE HISTORY RECORD REVIEW WAS ATTEMPTED FOR THE SUBJECT DEVICE. THE REVIEW COULD NOT BE COMPLETED BECAUSE THE DEVICE IS A LOT-CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 11-FEB-2008. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING DATES: DECEMBER 20, 2007 AND JANUARY 21, 2008. MANUFACTURING DATE: DECEMBER 20, 2007 AND JANUARY 21, 2008: REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. THE RAW MATERIAL IS CORRESPONDING TO THE SPECIFICATIONS. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. A PRODUCT INVESTIGATION WAS COMPLETED: PER THE TECHNIQUE GUIDE: THE RETURNED ALIF TRIAL SPACERS (03.808.113 AND 03.808.114) ARE PART OF THE LUMINARY ALIF SYSTEM. AFTER DISCECTOMY THE TRIAL SPACERS ARE USED WITH FINAL SPACER SIZE DETERMINATION IN ORDER TO SELECT THE APPROPRIATELY SIZED IMPLANT. THE RETURNED 11MM SPACER (03.808.113, A7QA51/5700484) WAS RECEIVED WITH THE SHAFT OF THE SPACER BROKEN FROM THE SPACER BODY SPECIFICALLY BROKEN AT THE REGION WHERE THE SHAFT IS LASER WELDED. THE RETURNED 13MM SPACER (03.808.114, A7PA13/5220889) WAS RECEIVED WITH A BROKEN THREADED REGION OF THE SPACER SLEEVE, WHICH IS INTENDED TO SCREW INTO THE SPACER HEAD. THE RELEVANT DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AND HANDLED AS RECOMMENDED. NO SERVICE HISTORY REVIEW COULD BE PERFORMED AS THE RETURNED PARTS ARE LOT CONTROLLED ITEMS. THE SERVICE HISTORY EVALUATIONS ARE UNCONFIRMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BOTH OF THE RETURNED PARTS WERE NON-REPAIRABLE PARTS FROM SERVICE AND REPAIR AND WERE SUBMITTED AFTER COMPLAINT CONDITIONS WERE NOTICED DURING SET INSPECTION, NOT DURING A PROCEDURE. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE 11MM SPACER (03.808.113, A7QA51/5700484) BREAKING FROM THE SPACER BODY AT THE REGION WHERE THE SHAFT IS LASER WELDED OR THE 13MM SPACER (03.808.114, A7PA13/5220889) BREAKING IN THE THREADED REGION OF THE SPACER. THE PROPERLY FITTING SPACER IS INDICATED TO BE USED FOR SIZING SO THAT THE TALLEST CLINICALLY REASONABLE IMPLANT IS IMPLANTED TO MAXIMIZE SEGMENT STABILITY. IT IS POSSIBLE THAT THE COMPLAINT CONDITION IS THE CUMULATIVE EFFECT OF THE SPACER BEING EXPOSED TO EXCESSIVE AND/OR OFF-AXIS FORCES THROUGHOUT ITS TIME IN USE, WHICH COULD COMPROMISE THE VULNERABLE LASER WELDED REGION, EVENTUALLY CAUSING IT TO BREAK. THE SPACER WAS MANUFACTURED ACCORDING TO A PREVIOUS REVISION OF THE DRAWING AND A CHANGE WAS IMPLEMENTED ON FEBRUARY 10, 2006; HOWEVER, MANUFACTURING WAS ALLOWED TO USE TRIAL SPACER COMPONENTS FROM THE PREVIOUS DRAWING UNTIL AVAILABLE INVENTORY HAS BEEN CONSUMED. IT IS LIKELY THAT THE THREADED SLEEVE REGION WAS DESIGNED PER THE PRIOR REVISION SINCE MANUFACTURING WAS STILL USING THE REMAINING INVENTORY OF SLEEVES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    SERVICE AND REPAIR EVALUATION ¿ THE CUSTOMER REPORTED THE ITEM BROKE IN HALF. THE REPAIR TECHNICIAN REPORTED THE ITEM BROKE AT THE WELD POINT. DAMAGED COMPONENT IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO THE COMPLAINT HANDLING UNIT. THE EVALUATION WAS CONFIRMED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE SET INSPECTION AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) TRIAL SPACER WAS FOUND BROKEN IN HALF. IT IS UNKNOWN WHEN THE SPACER BROKE; HOWEVER, THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779675 ALIF TRIAL SPACER-QUICK RELEASE 11MM HEIGHT TEMPLATE HWT SYNTHES TUTTLINGEN 5700484

    Patients

    Seq Age Sex Outcome Treatment
    1