BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI VECTRA(TM) PLATE 1 LEVEL/14MM

    MDR report key: 3063736 · Received April 17, 2013

    Report

    Report Number
    8030965-2013-10930
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    September 1, 2011
    Report Date
    September 1, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    PMA / PMN Number
    K050451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 PRODUCT DEVELOPMENT EVENT EVALUATION REVEALED THAT THE PLATE SHOWS SIGNS OF USE IN THE FORM OF SCRATCHES, LOSS OF ANODIZE, AND CIRCULAR MARKINGS (INDICATING THE USE OF THE REMOVAL DRIVER). ONE OF THE SCREWS APPEARS TO BE BENT UP TOWARD THE INSTRUMENTATION, SOMETIMES FOUND FROM USING THE REMOVAL DRIVER. THERE IS NO EVIDENCE OF PLATE ABNORMALITIES, OTHER THAN THE AFOREMENTIONED DAMAGE MOST LIKELY FROM THE REMOVAL. THE MOVEMENT OF THE PLATE CAN BE CAUSED BY SEVERAL THINGS, LIKE OFF AXIS SCREW INSERTION, CANTILEVER FORCES FROM INSTRUMENTATION, AND NOT USING A TEMPORARY FIXATION PIN. ONCE THIS OCCURRED, THERE IS NOTHING INDICATING THE SCREW COULD NOT BE REMOVED USING THE REMOVAL DRIVER AND REINSERTED IN THE CORRECT LOCATION. THERE ARE NOT ENOUGH DETAILS TO ACCURATELY CONCLUDE WHAT CAUSED THE SHIFT AND WHETHER OR NOT THE PLATE STILL COULD HAVE BEEN SAFELY USED AT THAT POINT. THE COMPLAINT IS THEREFORE INDETERMINATE THE MANUFACTURING EVALUATION SHOWED THAT ONE CLIP IN THE LOCATION HOLE IS BROKEN AND DEFORMED. THE MEASURABLE DIMENSIONS DO MEET THE SPECIFICATIONS. THREE OF FOUR CLIPS ARE IN CORRECT POSITION. THE MICROSCOPIC VIEW SHOWS THAT ONE CLIP IS BROKEN AND DEFORMED. THIS IS THE FIRST AND ONLY COMPLAINT OF THIS PART AND LOT NUMBER RELATED TO THE EVENT AS PER DESCRIPTION. WE SUPPOSE THAT THE CLIP GOT DAMAGED DURING A MECHANICAL OVERLOADING SITUATION. IT IS CONCLUDED THAT THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT.

    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. ORIGINAL AWARENESS DATE IS (B)(6) 2011. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE INSERTING A SCREW FOR A C6-C7 ACDF, THE SCREW WENT THROUGH THE LOCKING CLIP AND MADE A LOUD CLICK AND SHIFTED THE PLATE. THE CLIP RETAINED THE SCREW AND SURGEON HAD TO BACK OUT THE PLATE AND SCREW. A DIFFERENT SIZE PLATE AND THE SAME SCREW WAS PLACED TO COMPLETE THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165711 TI VECTRA(TM) PLATE 1 LEVEL/14MM KWQ SYNTHES GMBH 3434893

    Patients

    Seq Age Sex Outcome Treatment
    1