BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 2883234 · Received December 21, 2012

    Report

    Report Number
    2530088-2012-01127
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANTED APPROXIMATELY THREE MONTHS PRIOR TO EXPLANT DATE. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER A MANUFACTURING RECORD REVIEW CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    PATIENT WITH OSTEOPOROTIC BONE WAS TREATED WITH MATRIX SYSTEM FUSION FROM LEVELS L1-S1 APPROXIMATELY 3 MONTHS AGO FOR DEGENERATIVE LUMBAR SCOLIOSIS. PART NUMBERS AND LOT NUMBERS OF IMPLANTED HARDWARE IS NOT KNOWN. ON AN UNKNOWN DATE, THE PATIENT RETURNED TO THE SURGEON AND EXAMINATION REVEALED THE PATIENT HAD DEVELOPED A KYPHOSIS ABOVE THE FUSION. PATIENT WAS RETURNED TO OR ON (B)(6) 2012 TO EXTEND THE CONSTRUCT 3 LEVELS TO T10. SURGEON INTENDED TO REMOVE 2 MATRIX POLY SCREWS FROM L1 BUT EXPERIENCED DIFFICULTY REMOVING THE LOCKING CAPS FROM BOTH SIDES. WHILE ATTEMPTING TO REMOVE THE CAPS, TWO OF THE RATCHET HANDLES BROKE. SURGEON WAS ABLE TO REMOVE THE CAPS USING THE THREADED PERSUADERS WITH RATCHET HANDLES FROM ANOTHER SET. THE CONSTRUCT WAS EXTENDED TO T10 WITH 2 PARALLEL CONNECTORS AND 6 MATRIX POLY SCREWS IN THE 3 VERTEBRAL BODIES ABOVE THE CONSTRUCT, AND DID NOT REPLACE THE SCREW IN L1 IN ORDER TO HAVE ROOM TO PLACE THE PARALLEL CONNECTORS. DUE TO POOR BONE PURCHASE, THE SURGEON DECIDED TO PUT CEMENT IN THE PEDICLES T10-T12 PRIOR TO SCREW PLACEMENT TO AUGMENT PURCHASE IN OSTEOPOROTIC BONE. THE EXPLANTED LOCKING CAPS AND MATRIX POLYAXIAL SCREWS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE HOSPITAL. THIS IS THE 1ST OF 26 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI MATRIX LOCKING CAP MATRIX LOCKING CAP NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention LOCKING CAPS, SCREW, RODS