BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP INTERSPINOUS SPACER SYSTEM

    MDR report key: 2435443 · Received February 1, 2012

    Report

    Report Number
    2953769-2012-00011
    Event Type
    Injury
    Date Received
    February 1, 2012
    Date of Event
    January 4, 2012
    Report Date
    January 4, 2012
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH AN OBSOLETE COMPRESSION FRACTURE UNDERWENT AN INTERSPINOUS PROCEDURE ON 2 LEVELS. APPROXIMATELY ONE MONTH POST-OP, THE PATIENT REQUIRED ANOTHER SURGICAL PROCEDURE TO REMOVE THE 2 IMPLANTS; THE PATIENT EXPERIENCED AN INFECTION AND STENOSIS FROM THE COLLAPSED OBSOLETE VERTEBRAL COMPRESSION FRACTURE. THE INFECTION WAS FOUND THROUGH LAB DATA. THERE WAS NO PUS OR NECROSIS OF TISSUE AROUND THE SITE. PATIENT STATUS IS REPORTED AS "GOOD" AT THIS TIME. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-STOP INTERSPINOUS SPACER SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SPINE LLC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention