BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 2852777 · Received November 30, 2012

    Report

    Report Number
    1030489-2012-02513
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 2, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    MAX
    PMA / PMN Number
    K073291
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A PROCEDURE AT L4-L5 VIA PLIF TO TREAT DEGENERATIVE SPONDYLOLISTHESIS. IT WAS REPORTED THAT L4 SCREWS AND CAGE(S) BACKED OUT. THIS WAS CONFIRMED DURING REGULAR FOLLOW UP EXAM. THE PATIENT COMPLAINS OF PAIN. A REVISION SURGERY WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H11L2802

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention