BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 10502676 · Received September 8, 2020

    Report

    Report Number
    3006630150-2020-04014
    Event Type
    Injury
    Date Received
    September 8, 2020
    Date of Event
    July 20, 2020
    Report Date
    September 8, 2020
    Manufacturer
    VERTIFLEX INC.
    Product Code
    NQO
    UDI-DI
    00884662000543
    PMA / PMN Number
    P140004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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: 101-9814, SERIAL: N/A, BATCH: 800188.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPACER SHIFTED AND THE PATIENT IS EXPERIENCING MORE PAIN. THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY (CT) AND THE PHYSICIAN CONTINUES TO MONITOR THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967014 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO VERTIFLEX INC. 101-9812 800255 00884662000543

    Patients

    Seq Age Sex Outcome Treatment
    1 Other