BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI VECTRA-T(TM) PLATE 3 LEVEL/51MM

    MDR report key: 5306189 · Received December 17, 2015

    Report

    Report Number
    1000562954-2015-10219
    Event Type
    Injury
    Date Received
    December 17, 2015
    Date of Event
    December 2, 2015
    Report Date
    December 2, 2015
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    KWQ
    PMA / PMN Number
    PK051665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: ONE (1) 3 LEVEL 51MM VECTRA T PLATE (PART NUMBER 450.573, LOT 9683870, MANUFACTURE OCTOBER 2015) WAS RETURNED WITH A COMPLAINT STATING THAT THE TRANSLATING BLUE PORTION (CARRIAGE) OF THE PLATE DETACHED FROM THE GREEN PORTION (BASE) OF THE PLATE INTRA-OPERATIVELY AND HAD TO BE REMOVED. THE PLATE WAS RETURNED WITH BOTH CARRIAGE PLATES ATTACHED TO THE BASE PLATE MEANING THAT PLATE WAS REASSEMBLED AT SOME POINT BEFORE ARRIVING AT THE COMPLAINT HANDLING UNIT. THE FINISH ON THE PEEN UNDERNEATH ONE OF THE LONG CARRIAGE PLATE (THAT PLATE THAT STATES THE LENGTH) WAS SCRATCHED, INDICATING THAT THIS WAS THE SIDE THAT MOST LIKELY DISENGAGED DURING SURGERY. IN ADDITION TO THE COMPLAINT CONDITION, THE WISHBONE CLIP OF ONE OF THE SCREW HOLES ON THE LONG CARRIAGE PLATE WAS COMPLETELY OFF AND THE OTHER WISHBONE CLIP WAS PARTIALLY PULLED OUT. THE CARRIAGE SPACER FOR THE SHORT CARRIAGE WAS STILL ATTACHED WHEN THE PLATE ARRIVED. NUMEROUS SCRATCHES WERE ON THE PLATE, PREDOMINANTLY AROUND THE SCREW HOLES. THE FULLY EXTRACTED WISHBONE CLIP WAS RETURNED AS WELL AS FOUR (4) CARRIAGE SPACERS. THE COMPLAINT IS CONFIRMED. PER THE TECHNIQUE GUIDE, THE VECTRA-T PLATE IS INTENDED FOR THE SPINAL FUSION OF THE ANTERIOR CERVICAL. THE PLATE OFFERS THE OPTION OF TOGGLING SCREWS AND IS DESIGNED FOR TRANSLATION. THE RELEVANT PRODUCT DRAWINGS WERE REVIEWED DURING THE INVESTIGATION AND NO DESIGN ISSUES WERE NOTED. ACCORDING TO THE NOTE ON ONE OF THE DRAWINGS, THE ENDS OF BASE PLATE ARE TO BE DEFORMED 0.3-0.45MM TO RETAIN THE CARRIAGE PLATES. VERIFICATION TESTED THE MECHANICAL FORCE NEEDED TO PULL THE CARRIAGE PLATE OFF FROM THE BASE PLATE AND DETERMINED THAT 190N-276N OF FORCE WAS REQUIRED TO REMOVE THE PLATE. THIS MET THE FUNCTIONAL AND DESIGN REQUIREMENT OF 150N. IN ORDER FOR THIS INCIDENCE TO OCCUR INTRA-OPERATIVELY, A LARGE AMOUNT OF EXCESSIVE FORCE HAD TO BE APPLIED TO THE PLATE BY THE USER. THE WISHBONE CLIPS ARE DESIGNED TO PREVENT THE SCREWS FROM BACKING OUT ONCE FULLY INSERTED. THE HEAVY SCRATCH MARKS AROUND THE TWO SCREW HOLES WITH THE DAMAGED/MISSING CLIPS INDICATE 2 OF THE 4 SCREWS THAT HAD TO BE REMOVED (PER THE COMPLAINT DESCRIPTION) WERE INSERTED IN THIS CARRIAGE. THE FORCE REQUIRED TO REMOVE THE FULLY INSERTED SCREWS WAS MOST LIKELY THE CAUSE OF THE WISHBONE CLIPS DISENGAGING. IT IS LIKELY THAT THE CARRIAGE PLATE DISENGAGE DUE TO EXCESSIVE FORCE APPLIED BY THE USER AND THE WISHBONE CLIP DISLODGED FROM THE FORCE REQUIRED TO REMOVE THE FULLY INSERTED SCREWS. HOWEVER, DUE TO THE CONDITION OF THE RETURNED ITEM AND THE LIMITED COMPLAINT DETAILS, THE TRUE ROOT CAUSE CANNOT BE DETERMINED. 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 DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    PATIENT INITIALS: (B)(4). PATIENT WEIGHT IS UNKNOWN. IMPLANT AND EXPLANT DATES: DEVICE WAS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 06OCTOBER2015. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    IT WAS REPORTED THAT DURING ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF) A 51MM 3 LEVEL VECTRA T PLATE WAS BEING APPLIED TO C4 - 7. ONE SCREW WAS PLACED AT C6 ON THE LEFT, ANOTHER WAS PLACED AT C7 ON THE RIGHT. SCREWS WERE BEING INSERTED AT C4 WHEN THE DOCTOR NOTICED THE TOP TRANSLATING SEGMENT OF THE PLATE DETACHED FROM THE STATIC SEGMENT. THE DOCTOR NEEDED TO REMOVE 4 SCREWS AND THE BROKEN IMPLANT. THERE WAS A FORTY-FIVE (45) MINUTE DELAY IN SURGERY. THE BROKEN IMPLANT WAS EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THE SURGERY WAS SUCCESSFULLY COMPLETED. ANOTHER 3 LEVEL 51 MM VECTRA T PLATE WAS NOT AVAILABLE BUT THE DOCTOR DETERMINED THE 54M PLATE FIT THE ANATOMY WELL. NO ADDITIONAL INFORMATION AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834436 TI VECTRA-T(TM) PLATE 3 LEVEL/51MM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SYNTHES MEZZOVICO 9683870

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention