BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 11175550 · Received January 14, 2021

    Report

    Report Number
    3006630150-2020-06674
    Event Type
    Injury
    Date Received
    January 14, 2021
    Date of Event
    December 16, 2020
    Report Date
    January 12, 2021
    Manufacturer
    VERTIFLEX INC.
    Product Code
    NQO
    UDI-DI
    00884662000550
    PMA / PMN Number
    P140004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SUPERION IMPLANT UPN: (B)(4), MODEL: 101-9814, SERIAL: N/A, BATCH: 800256.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOMETIME POST IMPLANT, THE PATIENT HAD A SPINOUS PROCESS FRACTURE. IT WAS ASSESSED THAT THE PATIENT HAD OSTEOPOROSIS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71394 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO VERTIFLEX INC. 101-9814 800275 00884662000550

    Patients

    Seq Age Sex Outcome Treatment
    1