BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 17166675 · Received June 20, 2023

    Report

    Report Number
    3006630150-2023-03541
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    May 30, 2023
    Report Date
    June 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NQO
    UDI-DI
    00884662000536
    PMA / PMN Number
    P140004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SUPERION IMPLANT, UPN: 101-9810, MODEL: 101-9810, SERIAL: N/A, BATCH: 800098.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE TWO SUPERION INDIRECT DECOMPRESSION SYSTEM DEVICES WERE EXPLANTED IN ORDER TO PERFORM A LAMINECTOMY. THERE WAS NO DEVICE MALFUNCTION SUSPECTED. THE DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE FACILITY. THIS IS THE REPORT FOR THE SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525735 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO BOSTON SCIENTIFIC NEUROMODULATION 101-9810 800098 00884662000536

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown Required Intervention