BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 11181199 · Received January 15, 2021

    Report

    Report Number
    3006630150-2020-06696
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    December 21, 2020
    Report Date
    February 11, 2021
    Manufacturer
    VERTIFLEX INC.
    Product Code
    NQO
    UDI-DI
    00884662000543
    PMA / PMN Number
    P140004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A SEROMA AFTER AN IMPLANT PROCEDURE. THE PATIENT WAS MONITORED AND TREATED WITH ANTIBIOTICS. THE PATIENT WAS LATER HOSPITALIZED FOR HIP ISSUES AND HER BACK BEGAN LEAKING PURULENT FLUID. A CULTURE WAS PERFORMED AND IT TESTED POSITIVE FOR AN INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THEN UNDERWENT AN EXPLANT PROCEDURE TO REMOVE BOTH SPACERS. NO PRODUCTS WILL BE RETURNED PER FACILITY POLICY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS HEALING AND SLOWING IMPROVING.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SUPERION IMPLANT, UPN: (B)(4), MODEL: 101-9810, SERIAL: N/A, BATCH: 800306.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A SEROMA AFTER AN IMPLANT PROCEDURE. THE PATIENT WAS MONITORED AND TREATED WITH ANTIBIOTICS. THE PATIENT WAS LATER HOSPITALIZED FOR HIP ISSUES AND HER BACK BEGAN LEAKING PURULENT FLUID. A CULTURE WAS PERFORMED AND IT TESTED POSITIVE FOR AN INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THEN UNDERWENT AN EXPLANT PROCEDURE TO REMOVE BOTH SPACERS. NO PRODUCTS WILL BE RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74134 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO VERTIFLEX INC. 101-9812 800322 00884662000543

    Patients

    Seq Age Sex Outcome Treatment
    1