BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI VECTRA(TM) PLATE 3 LEVEL/54MM

    MDR report key: 3094217 · Received May 6, 2013

    Report

    Report Number
    8030965-2013-02117
    Event Type
    Injury
    Date Received
    May 6, 2013
    Report Date
    April 9, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    PMA / PMN Number
    K050451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFG EVALUATION: AS RECEIVED CONDITION: DEVICE WAS IN A USED CONDITION WITH DIFFERENT DISCOLORATIONS AND SCRATCHES NOTED. THE WISHBONE CLIPS WERE PARTIALLY DEFORMED, EITHER CAUSED DURING INSERTION, IN SITU OR EXTRACTION. CONCLUSION: THE RELEVANT FEATURES WERE INSPECTED AND NO DEVIATION WAS FOUND. NO MANUFACTURING RELATED FAULT COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICES WERE REVIEWED BY PRODUCT DEVELOPMENT, EVALUATION AS FOLLOWS: THE VECTRA PLATE AND SCREWS ARE DEVICES USED TO ASSIST IN ANTERIOR CERVICAL FUSION. THESE IMPLANTS ARE FOUND IN THE VECTRA, VECTRA-T, AND VECTRA-ONE TECHNIQUE GUIDE ((B)(4)). ALTHOUGH, ONLY ONE OF THE SCREWS HAD BACKED OUT, THE PLATE AND ALL OF THE SCREWS WERE RETURNED. THE COMPLAINT SPECIFICALLY STATES THAT THE SURGEON NOTICED THAT THE COMPLAINED SCREW WAS NOT THREADED INTO BONE WITH GOOD PURCHASE, BUT WAS IMPLANTED INTO VOID SPACE. THE RETAINING CLIPS IN THE PLATE ARE ALL DAMAGED, BUT THIS MAY HAVE OCCURRED DURING THE REMOVAL PROCESS. THE (B)(4) ENGINEER REVIEWED DRAWINGS (B)(4), AND 04 613 245 1 REV D. ALL MATERIALS AND SPECIFICATIONS ARE ADEQUATE FOR THE DEVICES INTENDED USE. BASED ON U.S. SALES OF VECTRA SCREWS FROM 4/2005 TO 9/2013, THE OCCURRENCE RATE OF SCREWS BACKING OUT IS APPROXIMATELY (B)(4). THE DESIGN RISK ASSESSMENT WAS REVIEWED AND IS ADEQUATE FOR THE INTENDED USE. THE SCREW APPEARS TO HAVE BACKED OUT DUE TO INITIAL IMPLANTATION IN A VOID SPACE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, A PATIENT UNDERWENT A 3-LEVEL (C4-7) ANTERIOR CERVICAL DECOMPRESSION FUSION (ACDF) PROCEDURE USING VECTRA AND ANTERIOR CERVICAL FUSION (ACF) SPACERS. DURING A FOLLOW-UP EXAMINATION, AN X-RAY REVEALED PSEUDOARTHROSIS AND THAT ONE OF THE INFERIOR VECTRA SCREWS APPEARED TO HAVE BACKED OUT. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013 AND THE VECTRA T-PLATE AND EIGHT VARIABLE ANGLE SELF-TAPPING 4.0MM SCREWS WERE REMOVED. A VECTRA T-PLATE AND FOUR VARIABLE ANGLE SCREWS WERE INSTALLED. DURING THE REVISION SURGERY, THE SURGEON NOTICED THAT A SCREW HAD BEEN IMPLANTED INTO A VOID SPACE AND HAD NO BONE PURCHASE. THE SURGEON ALSO REPORTED THAT THE END PLATES HAD ERODED AWAY. THIS IS REPORT 1 OF 9 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195890 TI VECTRA(TM) PLATE 3 LEVEL/54MM KWQ SYNTHES GMBH 1737670

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention