BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 6916562 · Received October 5, 2017

    Report

    Report Number
    1030489-2017-02153
    Event Type
    Injury
    Date Received
    October 5, 2017
    Report Date
    September 8, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    UDI-DI
    00613994290960
    PMA / PMN Number
    K073291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    D4: ALTHOUGH IT IS UNKNOWN IF THE DEVICES LED TO THE EVENT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES. FOLLOWING DEVICES WERE INVOLVED: PART# 2991222; LOT# H5307743; QTY 2.: NEITHER THE DEVICES NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR LUMBAR FUSION DUE TO DISC HERNIATION. POST-OP, INTER-VERTEBRAL SPACE INFECTION WAS OBSERVED ACCOMPANIED BY FEVER DISCOMFORT. PATIENT WAS HOSPITALIZED. PRODUCTS REMAIN IN THE PATIENT'S BODY. POST-OPERATIVE DEBRIDEMENT SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695829 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG NA H5307743 00613994290960

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other