BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERION INTERSPINOUS SPACER

    MDR report key: 12061453 · Received June 24, 2021

    Report

    Report Number
    3006630150-2021-03194
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 24, 2021
    Manufacturer
    VERTIFLEX INC.
    Product Code
    NQO
    PMA / PMN Number
    P140004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE SPACER IMPLANT SITE, THEREFORE, THE PATIENT UNDERWENT A SPACER EXPLANT PROCEDURE. POST-OPERATIVELY THE PATIENT HAS RECOVERED. THERE WAS NO SUSPECTED DEVICE ISSUE AND THE DEVICE WILL NOT BE RETURNED AS IT WAS RETAINED BY THE MEDICAL FACILITY. NO FURTHER INFORMATION HAS BEEN OBTAINED REGARDING THE MODEL OR LOT NUMBER OF THE DEVICE DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955994 SUPERION INTERSPINOUS SPACER PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO VERTIFLEX INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention