BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 4953233 · Received July 30, 2015

    Report

    Report Number
    2530088-2015-10528
    Event Type
    Injury
    Date Received
    July 30, 2015
    Report Date
    July 16, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    PK100952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT INVESTIGATION WAS COMPLETED: ALL RETURNED LOCKING CAPS (04.632.000 LOTS 7101508 X3, 7233034) WERE EXAMINED UNDER MAGNIFICATION. IN EACH INSTANCE EXPECTED WEAR CONSISTENT WITH INSERTION AND EXPLANTATION WERE VISIBLE (WORN ANODIZATION). THE THREAD PROFILES WERE FOUND TO BE FREE OF NICKS/GOUGES AND THE THREADS WERE SHARP AND WELL DEFINED IN EACH INSTANCE. A DEFINITIVE ROOT CAUSE FOR LOCKING CAP LOOSENING WAS UNABLE TO BE DETERMINED. THE SYSTEM TECHNIQUE GUIDE STATES THAT FINAL LOCKING CAP TIGHTENING BE CARRIED OUT WITH A 10NM TORQUE HANDLE (03.620.061); LOOSENING OF A LOCKING CAP IS INDICATIVE OF INADEQUATE TORQUE APPLICATION DURING INSERTION OR IMPROPER ALIGNMENT OF THE ROD WITH RESPECT TO THE POLYAXIAL HEADS. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. RELEVANT DRAWINGS FOR THE RETURNED IMPLANTS WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. 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

    (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. MANUFACTURE DATE: 27NOVEMBER 2012. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE 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.

    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.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 10 FOR (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTED THE FOLLOWING EVENT: SURGEON HAD TO SCHEDULE A REVISION SURGERY ON A PATIENT WHO HAD THE INITIAL SURGERY ON (B)(6) 2013. THE PATIENT WAS IMPLANTED WITH THE MATRIX CONSTRUCT FROM L4-L5. THE REVISION SURGERY ON (B)(6) 2015 WAS DUE TO NONUNION BETWEEN L4- L5; POSTOPERATIVE PAIN AND ADJACENT LEVEL DISEASE WAS ALSO REPORTED. DURING THE REVISION SURGERY THE ENTIRE MATRIX CONSTRUCT WAS EXPLANTED. UPON HARDWARE REMOVAL, THE SURGEON NOTICED THAT THE RIGHT L4 SCREW (PART# 04.606.655) HAD A LOOSE CAP AND THAT THE HEAD OF THE SCREW HAD POPPED OUT OF THE SCREW SHAFT (ALTHOUGH THE SCREW SHAFT WAS SOLID IN THE PEDICLE OF THE SPINE). THE LEFT L4 SCREW (04.606.650) ON THE OTHER HAND HAS A TIGHT SCREW, BUT THE SCREW ITSELF INTO THE BONE WAS LOOSE. THE SURGEON BELIEVES THAT THE LOOSE CAP ALONG WITH THE LOOSE SCREW PREVENTED HEALING POSSIBLY DUE TO MICROMOVEMENTS. THE PATIENT WAS THEN IMPLANTED WITH NON-SYNTHES PRODUCT BETWEEN LEVELS L2-L5. THIS IS REPORT 3 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495714 TI MATRIX LOCKING CAP ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE 7101508

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention