BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 12701848 · Received October 26, 2021

    Report

    Report Number
    3006630150-2021-06007
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    September 29, 2021
    Report Date
    November 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NQO
    UDI-DI
    00884662000550
    PMA / PMN Number
    P140004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED SPACER WAS ANALYZED AND REVEALED SEVERE ABRASION ON THE MATING SURFACE OF THE ACTUATOR. HOWEVER, THE IMPLANT FUNCTIONED ACCEPTABLY DURING THE FUNCTIONAL TEST. THE DAMAGE TO THE IMPLANT INDICATES FAILURE WAS LIKELY DUE TO DEPLOYMENT AGAINST RESISTANCE SUCH AS BONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE DEVICE BROKE, A SECOND DEVICE WAS ATTEMPTED TO BE IMPLANT AND IT ALSO BROKE. IT WAS INDICATED THAT THE DEVICES WERE CONNECTED TO THE INSERTER CORRECTLY. A THIRD DEVICE WAS USED TO COMPLETE THE DEVICE SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED ONLY ONE SPACER WAS DAMAGED DURING THE PROCEDURE AND NOT TWO.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SUPERION IMPLANT, UPN: 101-9814, MODEL: 101-9814, SERIAL: N/A, BATCH: 800289.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE DEVICE BROKE, A SECOND DEVICE WAS ATTEMPTED TO BE IMPLANT AND IT ALSO BROKE. IT WAS INDICATED THAT THE DEVICES WERE CONNECTED TO THE INSERTER CORRECTLY. A THIRD DEVICE WAS USED TO COMPLETE THE DEVICE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598812 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO BOSTON SCIENTIFIC NEUROMODULATION 101-9814 800289 00884662000550

    Patients

    Seq Age Sex Outcome Treatment
    1 Female