BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI VECTRA(TM) PLATE 2 LEVEL/30MM

    MDR report key: 11610784 · Received April 2, 2021

    Report

    Report Number
    8030965-2021-02576
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    February 8, 2021
    Report Date
    March 18, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    PMA / PMN Number
    K050451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. A VECTRA-PLATE WAS RETURNED TO DEPUY SYNTHES ZUCHWIL FOR EVALUATION. DEPUY SYNTHES CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. THE VISUAL INSPECTION CONFIRMED THAT THE VECTRA-PLATE IS DAMAGED AT ONE HOLE. THE WISHBONE CLIP IS DEFORMED/BENT. THE PLATE PRESENTS NORMAL SIGNS OF USE. THE ANODIZED LAYER IS PARTIALLY WORN. DIMENSIONS COULD NOT BE CHECKED DUE TO THE DAMAGE INCURRED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE STERILE AND NON-STERILE DEVICE LOT NUMBERS, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE VECTRA PLATE IS MADE FROM TITANIUM ALLOY (TI AL6 NB7) THE INVOLVED NON-STERILE LOT# L008740 HAS BEEN MANUFACTURED ASSEMBLING THE WHISBONE CLIPS ART. 50162826 LOT 9935638 ACCORDING TO THE PROCEDURE SM_705009 REV AD WHICH AFTER ASSEMBLING REQUIRES A FUNCTIONAL CHECK OF THE WISHBONE CLIP MOUNTED IN EACH PLATE HOLES. NO NON-CONFORMANCES HAVE BEEN IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE GIVEN INFORMATION INDICATES THAT THE PLATE GOT DAMAGED INTRA-OPERATIVE DURING SCREW REMOVAL. AS NO MANUFACTURING RELATED DEFICIENCY WAS FOUND IT CAN BE CONCLUDED THAT THE DAMAGE IS DUE TO UNINTENDED FORCES. AS PART OF DEPUY SYNTHES¿ QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE DEVICE HISTORY LOT : THIS MRE REVIEW IS FOR STERILIZATION PROCEDURE ONLY PART: 04.613.130S, LOT: L082405, MANUFACTURING SITE: SELZACH , SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 03.AUGUST 2016 , EXPIRY DATE: 01.JULY 2026 . A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART WAS MANUFACTURED IN MEZZOVICO PART: 04.613.130, LOT: L008740, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: 09.JUNE 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED AN ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION) SURGERY AT C5-7 WAS PERFORMED. AFTER THE SCREW (UNK) WAS INSERTED, THE SURGEON TRIED TO REMOVE IT FOR CHANGING INSERTION ANGLE. WHILE THE SCREW WAS BEING REMOVED, IT WAS FOUND THAT THE LOCKING AREA ON THE PLATE HAD BEEN DAMAGED. THE PROCEDURE WAS DELAYED LESS THAN 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. A VECTRA-PLATE WAS RETURNED TO DEPUY SYNTHES ZUCHWIL FOR EVALUATION. DEPUY SYNTHES CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. THE VISUAL INSPECTION CONFIRMED THAT THE VECTRA-PLATE IS DAMAGED AT ONE HOLE. THE WISHBONE CLIP IS DEFORMED/BENT. THE PLATE PRESENTS NORMAL SIGNS OF USE. THE ANODIZED LAYER IS PARTIALLY WORN. DIMENSIONS COULD NOT BE CHECKED DUE TO THE DAMAGE INCURRED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE STERILE AND NON-STERILE DEVICE LOT NUMBERS, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE VECTRA PLATE IS MADE FROM TITANIUM ALLOY (TI AL6 NB7) PER ISO 5832-11. THE INVOLVED NON-STERILE LOT# L008740 HAS BEEN MANUFACTURED ASSEMBLING THE WISHBONE CLIPS ART. 50162826 LOT 9935638 ACCORDING TO THE PROCEDURE WHICH AFTER ASSEMBLING REQUIRES A FUNCTIONAL CHECK OF THE WISHBONE CLIP MOUNTED IN EACH PLATE HOLES. NO NON-CONFORMANCES HAVE BEEN IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE GIVEN INFORMATION INDICATES THAT THE PLATE GOT DAMAGED INTRA-OPERATIVE DURING SCREW REMOVAL. AS NO MANUFACTURING RELATED DEFICIENCY WAS FOUND IT CAN BE CONCLUDED THAT THE DAMAGE IS DUE TO UNINTENDED FORCES. AS PART OF DEPUY SYNTHES¿ QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE DEVICE HISTORY LOT THIS MRE REVIEW IS FOR STERILIZATION PROCEDURE ONLY PART: 04.613.130S, LOT: L082405, MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: AUGUST 03, 2016, EXPIRY DATE: JULY 01, 2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART WAS MANUFACTURED IN (B)(4). PART: 04.613.130, LOT: L008740, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: JUNE 09, 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION) AT C5-7, AFTER THE SCREW WAS INSERTED, THE SURGEON TRIED TO REMOVE IT TO CHANGE THE INSERTION ANGLE. WHILE THE SCREW WAS BEING REMOVED, IT WAS FOUND THAT THE LOCKING AREA ON THE PLATE HAD BEEN DAMAGED. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT. THE PROCEDURE WAS DELAYED LESS THAN 30 MINUTES. CONCOMITANT DEVICE: VECTRA-PL 4/4.5 2 SEGMENTS L39 TAN BLUE (PART: 04.613.130S, LOT: L082405, QUANTITY 1). THIS REPORT IS FOR ONE (1) TI VECTRA(TM) PLATE 2 LEVEL/30 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505384 TI VECTRA(TM) PLATE 2 LEVEL/30MM APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ SYNTHES GMBH L082405

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - LOCKING/SET SCREWS