BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 11121106 · Received January 5, 2021

    Report

    Report Number
    3006630150-2020-06574
    Event Type
    Injury
    Date Received
    January 5, 2021
    Date of Event
    December 8, 2020
    Report Date
    April 2, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NQO
    UDI-DI
    00884662000567
    PMA / PMN Number
    P140004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICES WERE ANALYZED AND FOUND; SUPERION IMPLANT, LOT NUMBER 800130. THE CAM-LOBES WERE SIGNIFICANTLY BENT. THE DAMAGED CAM LOBES SUGGEST THAT THE USER LIKELY EXERTED EXCESSIVE FORCE WHILE ATTEMPTING TO DEPLOY THE IMPLANT AGAINST A RIGID OBSTRUCTION (SPINOUS PROCESS) DURING THE IMPLANT PROCEDURE. THE COMPLAINT OF THE SUPERION IMPLANT HAVING A BENT CAM LOBE WAS CONFIRMED THROUGH PRODUCT ANALYSIS. THE PROBABLE CAUSE HAS BEEN TRACED TO UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. SUPERION IMPLANT, LOT NUMBER 800256. THE IMPLANT EXHIBITS NORMAL CHARACTERISTICS. THE COMPLAINT OF THE IMPLANT BECAME DISLODGED AFTER PATIENT FELL COULD NOT BE CONFIRMED WITH TESTING OF THE PRODUCT RETURN AS NO PROBLEM HAS BEEN DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD A FALL AFTER LIFTING SOMETHING HEAVY. THE PATIENT THEN EXPERIENCED LOSS OF EFFICACY. X-RAYS SHOWED THAT THE IMPLANT AT L3/4 HAD A BENT UPPER LEFT CAM LOBE AND THAT THE IMPLANT AT L4/5 HAD DISLODGED FROM THE INTERSPINOUS SPACE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IMPLANT AT L3/4 WAS REMOVED AND REPLACED WITH A NEW IMPLANT AND THE IMPLANT AT L4/5 WAS REMOVED. THE PATIENT WAS DOING WELL POST OPERATIVELY.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SUPERION IMPLANT, UPN: 101-9814, MODEL: 101-9814, SERIAL: N/A, BATCH: 800256.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A FALL AFTER LIFTING SOMETHING HEAVY. THE PATIENT THEN EXPERIENCED LOSS OF EFFICACY. X-RAYS SHOWED THAT THE IMPLANT AT L3/4 HAD A BENT UPPER LEFT CAM LOBE AND THAT THE IMPLANT AT L4/5 HAD DISLODGED FROM THE INTERSPINOUS SPACE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IMPLANT AT L3/4 WAS REMOVED AND REPLACED WITH A NEW IMPLANT AND THE IMPLANT AT L4/5 WAS REMOVED. THE PATIENT WAS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16290 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO BOSTON SCIENTIFIC NEUROMODULATION 101-9816 800130 00884662000567

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention