BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRACEPT ACCESS INSTRUMENTS

    MDR report key: 14740036 · Received June 18, 2022

    Report

    Report Number
    3006789852-2022-00006
    Event Type
    Injury
    Date Received
    June 18, 2022
    Date of Event
    October 13, 2021
    Report Date
    February 16, 2022
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006189
    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 19 DAYS POST-OP. PATIENT WAS SUBSEQUENTLY TREATED WITH A L2 VERTEBROPLASTY//NO TERIPARATIDE. INTRACEPT TREATMENT OCCURRED ON L2-S1, 5 LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399164 INTRACEPT ACCESS INSTRUMENTS PROBE, RADIOFREQUENCY LESION AND ACCESSORIES GXI RELIEVANT MEDSYSTEMS, INC. FG 0060 127310221 00852454006189

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Unknown Disability| R