BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI VECTRA(TM) PLATE 2 LEVEL/36MM

    MDR report key: 4037218 · Received August 26, 2014

    Report

    Report Number
    1000562954-2014-10164
    Event Type
    Injury
    Date Received
    August 26, 2014
    Report Date
    July 29, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    KWQ
    PMA / PMN Number
    PK050451
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: RECEIVED A PLATE NOT IN THE ORIGINAL PACKAGING TOGETHER WITH (B)(4) SCREWS WHICH ARE NOT PART OF THIS INVESTIGATION. THE ETCHING ON PLATE MATCHES WITH REFERENCE NUMBERS REPORTED. RETURNED PLATE HAS BEEN REINSPECTED AS PER RELEVANT SPECIFICATIONS. THE VISUAL INSPECTION SHOWED NO VISUAL DEFECTS RELATED TO THE MANUFACTURING PROCESS; ONE HOLE IS VISUALLY DAMAGED POST PRODUCTION. ALL RELEVANT MEASURABLE PRODUCT FEATURES MEET SPECIFICATION, FUNCTIONAL TEST FOR WISH BONE CLIP PASSED FOR NON-DAMAGED HOLES AND WAS UNOBTAINABLE FOR THE DAMAGED HOLE BECAUSE THE WISH BONE CLIPS IS DAMAGED. CONSIDERING THAT ALL THE HOLES MANUFACTURED WITH THE SAME PARAMETERS AND TOOLS, THE CONCLUSION OF THE PRODUCT INVESTIGATION IS THAT THE COMPLAINED PART IS CONFORMING FROM A MANUFACTURING PERSPECTIVE. 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

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 NARRATIVE: THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. THUS, THE DOCUMENTS FOR THE CORRESPONDING NON STERILE PART 04.613.136 LOT 3680522 WERE REVIEWED WITH THE FOLLOWING RESULT: NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PLATE WAS IMPLANTED INTO THE PATIENT WITH CERVICAL SPONDYLOTIC MYELOPATHY (C4-6) ON (B)(6) 2014. AFTER C4-6 CERVICAL SPINE ANTERIOR FIXATION WAS DONE, IT WAS DETERMINED BY X-RAYS THAT ONE OF THE TWO SCREWS AT C4 HAD COME OFF AND THE HEAD OF THE OTHER SCREW HAD BACKED OUT. ALSO, THE CAGE BETWEEN C4 AND C5 WAS FOUND TO HAVE MIGRATED FORWARD A LITTLE AND THE PLATE ITSELF HAD SLIGHTLY SANK INTO THE CENTRUM. THERE WAS URGENT REVISION SURGERY WAS PLANNED THAT WAS PLANNED FOR ON (B)(6) 2014. IT WILL BE DETERMINED AT THE SURGERY WHETHER THE REPLACEMENT IS NEEDED FOR ALL OF THE IMPLANTS OR ONLY THE SCREWS. IT WAS ALSO REPORTED THAT THE ONLY ONE TYPE OF SCREWS, FIXED-ANGLE SCREWS, WERE USED IN THIS SURGERY FOR THE PATIENT WITH THE POOR QUALITY BONE. THERE WAS STRESS CONCENTRATED ON THE SCREWS AT THE MOST CRANIAL SIDE. THE SURGEON LOCKED THE IMPLANT ONE SIDE ONLY, SO IT IS ALSO CONSIDERED AS A POSSIBLE CAUSE. THERE WAS NO HARM TO THE PATIENT AND NO REPORT OF ANY SURGICAL DELAY. THIS REPORT IS 1 OF 4 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THE REVISION PROCEDURE OCCURRED. THE PLATE AND SIX SCREWS WERE REMOVED. ONLY THE TWO SCREWS AT C4 HAD BACKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516326 TI VECTRA(TM) PLATE 2 LEVEL/36MM APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ SYNTHES SELZACH 3695909

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention