BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 10830770 · Received November 12, 2020

    Report

    Report Number
    3006630150-2020-05522
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    October 27, 2020
    Report Date
    November 12, 2020
    Manufacturer
    VERTIFLEX INC.
    Product Code
    NQO
    UDI-DI
    00884662000536
    PMA / PMN Number
    P140004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SUPERION IMPLANT, UPN: (B)(4), MODEL: 101-9812, SERIAL: N/A, BATCH: 800311.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BACK PAIN. X-RAY SHOWED THAT THE IMPLANT WAS DISPLACED AND A POSSIBLE SPINOUS FRACTURE. THE PHYSICIAN ADVISED THE PATIENT TO WEAR A BRACE FOR 2 TO 3 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297186 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO VERTIFLEX INC. 101-9810 800136 00884662000536

    Patients

    Seq Age Sex Outcome Treatment
    1 Other