BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FACET WEDGE MED TAN GREEN

    MDR report key: 3820067 · Received May 20, 2014

    Report

    Report Number
    1000562954-2014-10085
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    April 23, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    KWP
    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 PMA/510 (K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 PRODUCT DEVELOPMENT EVENT EVALUATION WAS COMPLETED: ONE SCREW ON EACH FACET WEDGE IMPLANT IS JAMMED. MEASUREMENT OF THE RELEASE TORQUE HAS SHOWN THAT THE SCREW OF PART 1 COULD BE RELEASED WITH A TORQUE OF 0.89 NM. THE SCREW TIGHTENING IS LIMITED TO 1.2 NM BY THE TORQUE LIMITER IN THE FACET WEDGE SET (03.110.002) AND THE FAIL-SAFE FEATURE OF THE SCREWDRIVER WITHSTANDS 2.09 NM. PART 2 COULD NOT BE RELEASED. AN APPLIED TORQUE OF 1.99 NM COULD NOT RELEASE THE SCREW. THEREFORE THE IMPLANT WAS CUT OPEN TO INVESTIGATE THE REASON FOR THE INCREASED RELEASE TORQUE. MICROSCOPIC ANALYSIS SHOWED BONE FORMATION BETWEEN THE BOTTOM OF THE IMPLANT AND THE SCREW NECK AREA. AFTER AN IMPLANTATION TIME OF 5 MONTHS BONE FORMATION ON THE IMPLANT IS NOT UNUSUAL. THIS BONE FORMATION IS A REASONABLE EXPLANATION FOR AN INCREASED RELEASE TORQUE. THE REASON FOR THE SCREW REMAINING IN THE IMPLANT IS NOT COLD WELDING AS ASSUMED IN THE COMPLAINT DESCRIPTION. FOR PART 1 THE REASON FOR THE SCREW REMAINING IN THE IMPLANT IS NOT DETERMINED AS THE RELEASING TORQUE WAS MEASURED TO BE 0.89 NM. FOR PART 2 THE REASON FOR THE SCREW REMAINING IN THE IMPLANT IS BONE FORMATION IN THE IMPLANT. 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: ON (B)(6) 2013, THE PATIENT UNDERWENT A FACET WEDGE IMPLANTATION. IT WAS REPORTED THAT ON (B)(6), 2014 A REMOVAL AND IMPLANTATION OF A SCREW AND ROD SYSTEM WAS NECESSARY DUE TO PERSISTENT INSTABILITY AND COLD WELDING OF THE SCREWS AND THE MEDIAL PART OF THE FACET IS BROKEN OFF. THERE WAS NO REPORT OF A SURGICAL DELAY. THIS REPORT IS FOR 1 OF 4 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THERE IS SUBLUXATION OF THE ARTIFICIAL DISC. THERE MIGHT BE SUBSIDENCE OF SUPERIOR ARTIFICIAL ENDPLATE AGAINST L5, BUT THAT IS NOT ABLE TO BE VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300331 FACET WEDGE MED TAN GREEN APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP SYNTHES MEZZOVICO 7924151

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention