BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 9863516 · Received March 21, 2020

    Report

    Report Number
    3006630150-2020-01359
    Event Type
    Injury
    Date Received
    March 21, 2020
    Date of Event
    February 21, 2020
    Report Date
    March 21, 2020
    Manufacturer
    VERTIFLEX INC.
    Product Code
    NQO
    UDI-DI
    00884662000550
    PMA / PMN Number
    P140004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # 101-9814; LOT # 800159; DESCRIPTION: SUPERION IDS 14MM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AFTER THE PHYSICIAN PERFORMED A QUICK HIT THE HAMMER TO KNOCK DOWN THE SPACER, THE PHYSICIAN LAID THE HAMMER ON THE PATIENT AND THE HAMMER BURNED THE PATIENT. THE HAMMER IS NOT PART OF THE VERTIFLEX KIT. THE PATIENT IS REPORTEDLY DOING WELL AND RECOVERING FROM THE BURN CAUSED BY THE HAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326903 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO VERTIFLEX INC. 101-9814 800202 00884662000550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other