BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDUCTOS

    MDR report key: 2668172 · Received July 25, 2012

    Report

    Report Number
    1030489-2012-01219
    Event Type
    Injury
    Date Received
    July 25, 2012
    Date of Event
    May 4, 2012
    Report Date
    June 25, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7510600, PRODUCT CODE NEK WAS CLEARED IN THE UNITED STATES. (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7510600, PMA # P000054 WAS CLEARED IN THE UNITED STATES. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. REVIEW OF AP <(>&<)> LATERAL X-RAYS OF RIGHT TIBIA AND FIBULA SHOW OPEN COMMINUTED M/3-D/3 TIBIAL FRACTURE WITH POXIMAL FIBULA FRACTURE. ORIF WITH LOCKING PLATE LEFT LARGE FRACTURE GAPS WHICH LED TO NONUNION. REVISION FOR NONUNION WITH BMP LEADS TO INFECTION. FINAL PICS SHOW ESTABLISHED PSEUDOARTHROSIS WITH PLATE REMOVED AND POSTERIOR THROUGH NONUNION. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE PATIENT UNDERWENT A SURGERY TO TREAT A NON-UNION OF THE RIGHT TIBIA USING CANCELLOUS PLASTIC WITH RHBMP-2/ACS. AFTER THE SURGERY, THE PATIENT DEVELOPED A BROAD INFECTION AT THE SURGICAL SITE. 4 DAYS POST-OP, THE PATIENT UNDERWENT A REVISION TO REMOVE THE IMPLANTS. ANTIBIOTICS WERE GIVEN, AND CULTURES WERE TAKEN. CULTURES FOUND PROPRIONIUMBACTERIUM ACNES. 27 DAYS AFTER THE REVISION SURGERY, THE PATIENT WAS DEMONSTRATING PATHOLOGICAL MOVEMENT, LITTLE PAIN, AND NO WEIGHT BEARING. 33 DAYS POST-REVISION, THE PATIENT'S SCAR AREA HAD REDUCED SENSITIVITY, AND DELAYED WOUND HEALING AFTER THE REVISION SURGERY TO TREAT THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDUCTOS NEK MEDTRONIC SOFAMOR DANEK USA, INC NA F54560

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention