BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP PEEK INTERSPINOUS SPACER

    MDR report key: 4200569 · Received October 24, 2014

    Report

    Report Number
    1030489-2014-04129
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    March 1, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 A PATIENT UNDERWENT A DECOMPRESSION SURGERY AT L4-L5 USING A INTERSPINOUS INTERBODY SPACER. IT WAS REPORTED THAT 161 DAYS POST-OP, THE PATIENT EXPERIENCED AN INCREASE IN LOW BACK SYMPTOMS DUE TO PERFORMING EXERCISES PRESCRIBED BY PHYSICAL THERAPY. THE PAIN PROGRESSED OVER THE LAST SIX MONTHS AND REPORTEDLY INTERFERES SOMEWHAT WITH PATIENT'S DAILY ACTIVITIES. ACCORDING TO THE REPORT, NO INTERVENTION OR TREATMENT HAS BEEN PROVIDED AND IT IS UNKNOWN WHETHER THE NEW SYMPTOMS WERE RELATED TO THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678511 X-STOP PEEK INTERSPINOUS SPACER PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SOFAMOR DANEK NA 2314671

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR