BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 9950449 · Received April 10, 2020

    Report

    Report Number
    3006630150-2020-01735
    Event Type
    Injury
    Date Received
    April 10, 2020
    Date of Event
    February 28, 2020
    Report Date
    June 1, 2020
    Manufacturer
    VERTIFLEX INC.
    Product Code
    NQO
    UDI-DI
    00884662000536
    PMA / PMN Number
    P140004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE TWO SPACERS WERE BROKEN SO THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT HARM REPORTED. THE SPACERS WERE KEPT BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOT NUMBER OF THE SECOND SPACER WAS 800090, NOT 800080.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # 101-9808; LOT # 800080; DESCRIPTION: SUPERION IDS 8MM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE TWO SPACERS WERE BROKEN SO THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT HARM REPORTED. THE SPACERS WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413546 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO VERTIFLEX INC. 101-9810 700039 00884662000536

    Patients

    Seq Age Sex Outcome Treatment
    1 Other