BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 12701849 · Received October 26, 2021

    Report

    Report Number
    3006630150-2021-06008
    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

    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 · 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 ONLY ONE DEVICE WAS DAMAGED DURING THE PROCEDURE AND WAS RETURNED FOR ANALYSIS. THIS IS A DUPLICATE REPORT PLEASE SEE MFR REPORT # 630150-2021-06007.

    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
    1598809 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