BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE VERTEBRAL BODY SPACER

    MDR report key: 6683790 · Received July 3, 2017

    Report

    Report Number
    1030489-2017-01653
    Event Type
    Injury
    Date Received
    July 3, 2017
    Report Date
    August 10, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (ALLERGIC REACTION) . 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER, A LIKE DEVICE WITH PART# 2990822, 510K# K073291 AND UPN (B)(4) IS APPROVED FOR USE IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE PATIENT COMPLAINED OF ALLERGIC REACTION ON HER SKIN WHICH STARTED ON HER BACK AND IS SPREADING NOW OVER HER WHOLE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464644 CAPSTONE VERTEBRAL BODY SPACER INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG NA H10E0702

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other