BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE® SPINAL SYSTEM

    MDR report key: 3756927 · Received April 17, 2014

    Report

    Report Number
    1030489-2014-02217
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    K073291
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 2991432, PRODUCT CODE MAX WAS CLEARED IN THE UNITED STATES. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 2991432, 510K # K073291, WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. IT WAS NOTED THAT AT AN UNKNOWN TIME POST-OP, IT WAS REPORTED THAT THE CAGE MIGRATED AND THE PATIENT COMPLAINED OF RADICULAR PAIN. THE PATIENT UNDERWENT A REVISION SURGERY A NEW CAGE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235712 CAPSTONE® SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG H13J2030

    Patients

    Seq Age Sex Outcome Treatment
    1