BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 2944941 · Received February 6, 2013

    Report

    Report Number
    2530088-2013-00121
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 11, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A DESIGN EVALUATION CAN NOT DETERMINE THE CAUSE OF A PATIENT INFECTION. THE DESIGN RISK ASSESSMENT IS BEING REVIEWED FOR POSSIBLE UPDATE TO ADD THIS COMPLAINT EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PRODUCT CODE KWQ WAS PREVIOUSLY REPORTED INCORRECTLY AS KWO.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. LOCKING CAP RECEIVED IN A RELATIVELY PRISTINE CONDITION WITH ONLY MINOR IMPERFECTIONS ON THE ANODIZE FINISH. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. COMPLAINT DOES NOT INDICATE THE NEED FOR DIMENSIONAL INSPECTION. BASED ON THE EVENT OF PATIENT INFECTION THERE WOULD BE NO RELEVANT PRODUCT DIMENSIONS. IN ADDITION, PER THE PRODUCT COMPLAINT, THERE IS NO INDICATION THERE WAS AN ISSUE WITH THE PERFORMANCE OF THE DEVICE. PRODUCT ALSO MET RAW MATERIAL SPECIFICATIONS.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH HARDWARE AT L2-L5 ON (B)(6) 2012 FOR A DEGENERATIVE SPINE. PATIENT WAS SCHEDULED TO RETURN TO THE OR ON (B)(6) 2013 FOR A WASH OUT WITH PULSEVAC DUE TO AN INFECTION. REPORTEDLY, THE SURGEON REMOVED THE LOCKING CAPS AND THE RODS TO ENSURE THERE WAS NOT INFECTION UNDERNEATH. THE SURGEON ALSO REMOVED ONE SCREW BECAUSE IT WAS LOOSE AND TWO TRANSCONNECTORS. THE RODS AND THE LOCKING CAPS WERE REPLACED. THE OTHER ORIGINAL SCREWS REMAIN IMPLANTED. IT WAS REPORTED THAT THE SURGEON DOES NOT THINK THE INFECTION WAS CAUSED BY THE IMPLANTS. THE SURGERY WENT AS PLANNED, NO ISSUES WERE REPORTED. IT WAS ALSO REPORTED THAT THE 400MM ROD WAS INITIALLY CUT IN HALF PRIOR TO THE INITIAL SURGERY. THE HOSPITALS INTERNAL TESTING ON THE DEVICES REVEALED NO INFECTION. THIS IS 5 OF 13 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAS RETURNED THREE TIMES SINCE THE COMPLAINED HARDWARE WAS EXPLANTED, TWICE FOR DEBRIDEMENT AND WOUND VAC AND FINALLY ON (B)(6) 2013 FOR REVISION TO A COMPETITORS PLATES AND SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50896 TI MATRIX LOCKING CAP LOCKING CAP NKB SYNTHES BRANDYWINE 7026568

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention