BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI VECTRA(TM) PLATE 3 LEVEL/57MM

    MDR report key: 3091461 · Received May 3, 2013

    Report

    Report Number
    8030965-2013-02107
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    PMA / PMN Number
    K050451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ACCORDING TO THE DOCUMENT THIS WAS A LOT SIZE OF 5PCS AND 40PCS OF THE WISHBONE CLIP WERE REMOVED FROM STOCK BACK THEN, WHICH IS THE CORRECT AMOUNT FOR THIS 8-HOLE PLATE. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE CHU ENGINEER REVIEWED THE PRODUCT WITH THE FOLLOWING RESULTS: THE RETURN HAS MINOR SCRATCHES TO BOTH THE PROXIMAL AND DISTAL SURFACES. THE IMPLANT IS MISSING ALL EIGHT CLIPS. NO EVIDENCE OF TAMPERING IS PRESENT. THE VECTRA, VECTRA-T, AND VECTRA-ONE ANTERIOR CERVICAL PLATING SYSTEM INCLUDES SEVERAL IMPLANT OPTIONS. ALL THE PLATES IN THIS SYSTEM HAVE INTEGRAL ELGILOY CLIPS TO LOCK THE SCREWS. 04.613.257 IS A THREE LEVEL PLATE IN THE VECTRA FAMILY OF IMPLANTS. THIS SPECIFIC PART NUMBER MUST CONTAIN EIGHT CLIPS. THE CHU REVIEWED THE ASSEMBLY DRAWING (04_613_245 REV C). THIS DRAWING DETAILS THE APPROPRIATE DIMENSIONS, FINISHING PROCESSES, AND COMPONENTS FOR A SUCCESSFUL CERVICAL PLATE. THE PLATES HAVE GROOVE FEATURES TO SECURELY HOUSE THE ELGILOY CLIPS. THE CHU REVIEWED THE COMPLAINT HISTORY FOR THE ENTIRE VECTRA PLATE FAMILY. FROM APRIL 2011 TO APRIL 2013, THE HISTORY SHOWS 2 IMPLANTS WITH THIS FAILURE MODE. BASED ON SALES OF VECTRA PLATES FOR THE SAME TIME PERIOD IS 0.008%. THE RISK OF THIS COMPLAINT NEEDS TO BE ADDRESSED FROM A MANUFACTURING PERSPECTIVE. THE DESIGN RISK ANALYSIS IS NOT APPLICABLE. THE INVESTIGATION IS ONGOING. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MISSING TRACES AT THE CLIP HOLES INDICATE THAT THE CLIPS WERE NOT INSERTED DURING MANUFACTURING. THIS IS A MANUFACTURING FAULT. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A THREE LEVEL FUSION PROCEDURE FROM C4-C7 ON (B)(6) 2013, THE SURGEON COULD NOT SEAT THE PLATE. IT WAS REPORTED THAT THIS WAS BECAUSE THERE WERE NO LOCKING MECHANISMS OR ELIQILOY CLIPS ON ANY OF THE HOLES OF THE PLATE TO SEAT AND HOLD THE SCREWS. THE SURGEON REMOVED THE PLATE AND USED ANOTHER PLATE WITH THE SAME SCREWS. THIS CAUSED A DELAY OF 20 TO 25 MINUTES TO THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193950 TI VECTRA(TM) PLATE 3 LEVEL/57MM KWQ SYNTHES GMBH 3693878

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR