BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 11867525 · Received May 21, 2021

    Report

    Report Number
    3006630150-2021-02326
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 29, 2021
    Report Date
    May 21, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NQO
    UDI-DI
    00884662000543
    PMA / PMN Number
    P140004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SUPERION IMPLANT, UPN: 101-9812, MODEL: 101-9812, SERIAL: N/A, BATCH: 800197.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, TWO IMPLANTS BROKE. THE PROCEDURE WAS ABORTED. THE DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER AS THEY WERE DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764087 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO BOSTON SCIENTIFIC NEUROMODULATION 101-9812 700065 00884662000543

    Patients

    Seq Age Sex Outcome Treatment
    1 Other