BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP PEEK INTERSPINOUS SPACER

    MDR report key: 5080099 · Received September 16, 2015

    Report

    Report Number
    1030489-2015-02388
    Event Type
    Injury
    Date Received
    September 16, 2015
    Date of Event
    August 24, 2015
    Report Date
    August 24, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INTERSPINOUS SPACER SURGERY FOR LCS. CONFIRMING X RAY IMAGE POST-OP, THE SURGEON NOTICED THE CRANIAL WING OF THE UNIVERSAL WING ASSEMBLY WENT OVER INTER SPINOUS LIGAMENTS AND MOVED TO THE RIGHT SIDE. THE CONCERNED WING WAS REMOVED AND PLACED IN REVISION SURGERY. THE SURGICAL TIME WAS EXTENDED FOR ABOUT 30 -60 MINUTES. THE PRODUCT USED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. THE INTERSPINOUS SPACER (SIZE 12) WAS INSERTED AFTER EXPANDING WITH TRIAL 14. UNIVERSAL WING ASSEMBLE WAS PLACED AND COMPLETED THE INITIAL SURGERY. AFTER CHANGING A POSITION OF THE PATIENT, X-RAY FOUND THAT WING PART WAS TILTED AND CRANIAL PART WENT THROUGH INTER SPINOUS LIGAMENTS. THE REVISION SURGERY WAS OPERATED ON SAME DATE TO RE POSITION THE INTERSPINOUS SPACER. THE SURGEON TOLD THAT IT MIGHT BE DISLOCATED AT TIME OF THE POSITION CHANGE IMMEDIATELY AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613189 X-STOP PEEK INTERSPINOUS SPACER PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SOFAMOR DANEK USA, INC NA RM14G011

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention