BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP® INTERSPINOUS SPACER

    MDR report key: 2831839 · Received November 14, 2012

    Report

    Report Number
    1030489-2012-02177
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 15, 2012
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TWO DEVICES WITH DIFFERING LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 1-3210, LOT: 2237901 / MANUFACTURING DATE: NOV. 09, 2010 / EXPIRATION DATE: NOV. 30, 2012, PART: 1-3210, LOT: 2261011 / MANUFACTURING DATE: APR. 26, 2011 / EXPIRATION DATE: APR 30, 2013. ALTHOUGH IT IS UNKNOWN WHICH OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PARTICIPATING IN A CLINICAL STUDY WAS IMPLANTED WITH TWO 10-MM PEEK INTERSPINOUS SPACER DEVICES AT L3-L4 AND L4-L5. APPROXIMATELY 3 MONTHS POSTOPERATIVELY, THE SITE REPORTED "THE PATIENT FAILED MINIMALLY INVASIVE EFFORT IN THE FORM OF INTERSPINOUS PROCESS SPACER". THE EVENT WAS DESCRIBED IN THE REPORT AS "IMPLANT RELATED" AND "SEVERE". NO PATIENT SYMPTOMS WERE REPORTED AND IT IS UNKNOWN IF A REVISION SURGERY IS PLANNED. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR