BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 13795230 · Received March 17, 2022

    Report

    Report Number
    3006630150-2022-01063
    Event Type
    Injury
    Date Received
    March 17, 2022
    Date of Event
    March 2, 2022
    Report Date
    April 26, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NQO
    UDI-DI
    00884662000550
    PMA / PMN Number
    P140004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION OF THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER, 101-9814 (800153), REVEALED THAT THE ACTUATOR WAS MISALIGNED WITHIN THE IMPLANT BODY RESULTING IN SEVERE DAMAGE TO THE IMPLANT BODY AND SEVERELY STRIPPED SCREW THREAD. THE DAMAGE TO THE IMPLANT WAS SUFFICIENT TO PREVENT FUNCTIONAL TESTING AND IS BELIEVED TO HAVE OCCURRED DURING THE EXPLANT PROCEDURE. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) PRODUCT LABEL. ADDITIONALLY, PAIN AND DISCOMFORT ASSOCIATED WITH THE OPERATIVE SITE OR PRESENCE OF IMPLANTS AND FAILURE OF THE DEVICE OR PROCEDURE TO IMPROVE SYMPTOMS AND OR FUNCTION ARE NOTED WITHIN THE IFU AS A POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF THE DEVICE. BASED ON ALL AVAILABLE INFORMATION, BOSTON SCIENTIFIC ENGINEERS CONCLUDED THAT, PER THE LABELING REVIEW, THE REPORTED EVENTS OF PAIN AND INEFFECTIVE THERAPY ARE KNOWN INHERENT RISKS OF THE DEVICE. THE DAMAGE TO THE IMPLANT BODY, OBSERVED BY VISUAL INSPECTION, IS BELIEVED TO HAVE OCCURRED DURING THE EXPLANT PROCEDURE DUE TO AN UNINTENDED USE ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND INEFFECTIVE THERAPY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND INEFFECTIVE THERAPY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46620 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO BOSTON SCIENTIFIC NEUROMODULATION 101-9814 800153 00884662000550

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention