BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRACEPT ACCESS INSTRUMENTS

    MDR report key: 14740042 · Received June 18, 2022

    Report

    Report Number
    3006789852-2022-00008
    Event Type
    Injury
    Date Received
    June 18, 2022
    Report Date
    May 18, 2022
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    PMA / PMN Number
    K213836
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD A L2 COMPRESSION FRACTURE 35 DAYS POST-OP. PATIENT WAS SUBSEQUENTLY TREATED WITH A L2 VERTEBROPLASTY/ABALOPARATIDE. INTERCEPT TREATMENT OCCURRED ON L1-L2 LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399170 INTRACEPT ACCESS INSTRUMENTS PROBE, RADIOFREQUENCY LESION AND ACCESSORIES GXI RELIEVANT MEDSYSTEMS, INC. FG 0060

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Unknown Required Intervention| S