BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 3494732 · Received December 2, 2013

    Report

    Report Number
    2530088-2013-01302
    Event Type
    Injury
    Date Received
    December 2, 2013
    Report Date
    November 4, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT EVENT EVALUATION: THERE WERE A TOTAL OF FIFTEEN PARTS REMOVED AS PART OF AN EXPLANT SURGERY DUE TO POSSIBLE INFECTION. THIS INCLUDES TWO OF 5.5MM TI LINED HARD ROD 500MM (PART 04.633.395, LOT(S) UNKNOWN), ONE TI SNAP-ON TRANSCONNECTOR 38MM-47MM (PART 04.633.338, LOT 6763556), SIX TI MATRIX LOCKING CAPS (PART 04.632.000, LOTS 7122349(1), 7109338(1), 7060253(1), 7345572(1), AND 7400484(2)), AND SIX 6.0MM TI MATRIX POLYAXIAL SCREWS (PART 04.606.645, LOTS 7373377(2), 7357354(1), 7296521(1), AND 7363030(2)). THESE IMPLANTS ARE ALL USED IN THE MATRIX SYSTEM AND THEIR AND THE USE OF THESE IMPLANTS IS COVERED IN THE TECHNIQUE GUIDES (J9698-D, J9699-D, J9700-D). ALL BUT ONE OF THE RETURNED PARTS WAS FOUND TO MEET VISUAL REQUIREMENTS. (B)(4)

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED: TI MATRIX LOCKING CAP WAS RECEIVED WITH THE LOCKING SCREW AND SADDLE ASSEMBLED AS DESIGNED. THE SD25 FACE HAS NICKS AND SCRATCHES WITH MAJOR DEFORMATION TO THE FORM. 1ST THREAD ON SADDLE IS FLATTENED. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. TI MATRIX LOCKING CAP PERFORMED AS DESIGNED, THERE WAS SUCCESSFUL FUSION. THERE WILL BE NO RELEVANT SPECIFICATIONS ASSOCIATED WITH COMPLAINT CATEGORY "PATIENT INFECTION". RAW MATERIAL IS NOT RELEVANT TO COMPLAINT CATEGORY "PATIENT INFECTION" BECAUSE RAW MATERIAL PERFORMED AS DESIGNED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT POSTERIOR FUSION FROM T10-L1 FOR A T12 BURST FRACTURE ON (B)(6) 2013. PATIENT WAS RETURNED TO THE OPERATING ROOM FOR EXPLORATORY SURGERY ON (B)(6) 2013 DUE TO POSSIBLE INFECTION. UPON OPENING THE PATIENT THE SURGEON FOUND ALL IMPLANTED HARDWARE WAS INTACT, BUT DECIDED TO REMOVE THE HARDWARE FROM T10, T11 AND L1 DUE TO INFECTION. FIVE OF SIX LOCKING CAPS WERE EASILY REMOVED. THE LAST LOCKING CAP WOULD NOT COME OFF. THE SURGEON SPENT 45 MINUTES TRYING TO REMOVE THE CAP BEFORE USING VISE GRIPS AND ROD HOLDERS TO PULL THE SCREW OUT. DURING THE ATTEMPTED REMOVAL THE SURGEON BROKE THREE SCREWDRIVER SHAFTS, ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. AFTER THE HARDWARE WAS REMOVED, THE WOUND WAS CLEANED, AND WOUND-VAC WAS PLACED. PROCEDURE WAS COMPLETED SUCCESSFULLY. SURGEON NOTED THE PATIENT WAS SUCCESSFULLY FUSED AND STATUS WAS STABLE FOLLOWING SURGERY. THIS REPORT IS 11 OF 18 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623092 TI MATRIX LOCKING CAP NKB SYNTHES BRANDYWINE 7060253

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention