BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 12200533 · Received July 20, 2021

    Report

    Report Number
    3006630150-2021-03927
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    April 26, 2021
    Report Date
    July 20, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NQO
    UDI-DI
    00884662000536
    PMA / PMN Number
    P140004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SUPERION IMPLANT, UPN: 101-9808, MODEL: 101-9808, SERIAL: N/A, BATCH: 800146.

    Description of Event or Problem · 1

    DEVICE ANALYSIS PERFORMED ON THE RETURNED SPACER REVEALED THAT THE SPINDLE CAP WAS COMPLETELY SHEARED OFF FROM THE IMPLANT BODY. DAMAGE TO THE DEVICE PREVENTED FUNCTIONAL TESTING, HOWEVER, THIS DAMAGE TO THE SPACER INDICATES THE BREAK WAS DUE TO DEPLOYMENT AGAINST RESISTANCE. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU)/PRODUCT LABEL. ADDITIONALLY, DEVICE BREAKAGE CAN OCCUR WHEN USED WITH FORCED DEPLOYMENT AND IS NOTED WITHIN THE IFU AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093839 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO BOSTON SCIENTIFIC NEUROMODULATION 101-9810 800326 00884662000536

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR