BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM

    MDR report key: 3192497 · Received June 27, 2013

    Report

    Report Number
    2530088-2013-00986
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    October 14, 2011
    Report Date
    October 25, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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 RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EVALUATION REVEALED THAT THERE ARE VISIBLE MARKS ON THE RETURNED IMPLANT GIVING A CLEAR INDICATION THAT THE SCREW HEAD HAS NOT BEEN PLACED ACCORDINGLY BEFORE THE FINAL TIGHTENING WAS PERFORMED. THEREFORE, WE DO SUPPOSE THAT IT WAS POSSIBLE THAT THE POLY-AXIAL HEAD CAME LOOSE FROM THE SCREW ITSELF DURING PRIOR MANIPULATION OF THE SCREW HEAD. PLEASE NOTE THAT WE RECOMMEND THE USE OF EITHER THE HOLDING SLEEVE 03.632.001 OR 03.632.036 IN ORDER TO ALWAYS ENSURE THE CORRECT SEATING OF THE SCREW HEAD. WE DO ALSO RECOMMEND ALWAYS USING THE HEAD ALIGNMENT TOOL 03.632.007 IF SOME ALIGNMENT OF THE SCREW HEAD IS NECESSARY. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO DISCREPANCIES TO THE SPECIFICATIONS WERE FOUND. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE DOCTOR WAS PERFORMING A TLIF FOR LEVELS L2 TO L5, A LOCKED SCREW HEAD POPPED OFF. HE INSERTED STANDARD MATRIX SCREWS ON BOTH SIDES AT L2, L3, L4 AND L5 AND HE WENT ON TO CHANGE L3 SCREWS TO REDUCTION HEADS. AFTER HE INSERTED ALL SCREWS HE WENT TO LOCK DOWN THE ROD WITH THE CAPS STARTING AT L2. AS HE THEN LOCKED DOWN THE REDUCTION HEAD AT L3, THE HEAD AT L2, WHICH WAS PREVIOUSLY LOCKED DOWN, POPPED OFF. THE DOCTOR COMMENTED THAT THE L2 SCREW WAS SLIGHTLY OFFSET TO L3, WHICH COULD HAVE CONTRIBUTED TO EXTRA STRESS ON THE L2 SCREW HEAD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292936 PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM NKB SYNTHES BRANDYWINE 6729900

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR