BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP PEEK INTERSPINOUS SPACER

    MDR report key: 8296077 · Received February 1, 2019

    Report

    Report Number
    1030489-2019-00107
    Event Type
    Injury
    Date Received
    February 1, 2019
    Report Date
    February 1, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NQO
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 1-3212, PMA #P040001, UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH THAT ON AN UNKNOWN DATE, POST-OP, PATIENT HAD ANTERIOR SLIP DUE TO CAGE BREAKAGE. PATIENT UNDERWENT FUSION AT L5/L4/L3 IN WHICH CAGE WAS FITTED. AFTER 4 MONTHS, THE CAGE BROKE APART WHICH HAD MADE PATIENT BEDRIDDEN AND THE PATIENT HAD TO TAKE SEVERAL PAINKILLING INJECTIONS. AS AN EMERGENCY, THE IMPLANTED DEVICE WAS TAKEN OUT. PATIENT WAS PUT ON MORPHINE TILL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88759 X-STOP PEEK INTERSPINOUS SPACER PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SOFAMOR DANEK USA, INC NA 070214

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R