BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE

    MDR report key: 6878234 · Received September 20, 2017

    Report

    Report Number
    1030489-2017-02077
    Event Type
    Injury
    Date Received
    September 20, 2017
    Report Date
    August 21, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MQP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG # 2991026, 510K #K073291 AND (B)(4) WAS CLEARED IN THE UNITED STATES. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. HOWEVER X-RAYS WERE REVIEWED AND THEIR RESULTS ARE AS FOLLOWS: X-RAY REVIEW: "POST-OP CT/X-RAY FOR L4-5 TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) SHOW POSTERIOR DISPLACEMENT OF CAGE. REPORTED TO HAVE OCCURRED AFTER 9 YEARS FROM SURGERY, NO OTHER FILMS PROVIDED THAT SHOW INITIAL PLACEMENT IS OK. THERE IS NO BONE GROWTH IN THE INTERBODY SPACE AND IT LOOKS LIKE THERE IS A BONE REMODELING IN THE ANTERIOR INTERBODY SPACE SUGGESTING THE DEVICE WAS NOT PROPERLY INSERTED IN THE ORIGINAL SURGERY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MIS-TLIF (MINIMALLY INVASIVE SURGERY- TRANSFORAMINAL LUMBAR INTERBODY) AT L4/5 ABOUT 9 YEARS AGO IN WHICH THE CAGE WAS IMPLANTED AT L4/5 RIGHT, MULTI-AXIAL SCREWS WERE PLACED AT BOTH SIDES OF L4 AND L5 AND RODS WERE PLACED ON BOTH SIDES OF L4/5. POST-OP, THE CAGE WAS FOUND TO BACK OUT. NEUROLOGICAL SYMPTOM WAS DEVELOPED DUE TO CAGE BACK OUT. NO LOOSENING OF PLUGS OR SCREWS WAS REPORTED. ALL IMPLANTS WERE REMOVED COMPLETELY IN A REVISION SURGERY AND WERE REPLACED WITH COMPETITOR¿S IMPLANTS. THE PATIENT ISSUE HAS BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659278 CAPSTONE SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention