BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP® INTERSPINOUS SPACER SYSTEM

    MDR report key: 3086157 · Received April 30, 2013

    Report

    Report Number
    2953769-2013-00069
    Event Type
    Injury
    Date Received
    April 30, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 1-3212 / LOT: 2228531; PART: 1-3216 / LOT: 2241441. 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 UNDERWENT A PROCEDURE USING AN INTERSPINOUS SPACER TO TREAT LUMBAR CANAL STENOSIS AT L3/4 (12MM) AND L4/5 (16MM). EIGHTY-FOUR DAYS POST-OP, IT WAS REPORTED THAT A SPINOUS PROCESS FRACTURE WAS NOTED AT L4 ON CT SCANS. THERE WAS NO REPORT OF WORSENING OF SYMPTOMS AND NO COMPLAINT OF PAIN, ACCORDING TO THE REPORT. A SECOND SURGERY FOR REMOVAL OF THE IMPLANT, LAMINECTOMY AND FIXATION WAS PERFORMED. THE SURGEON COMMENTED THAT "THE SECOND SURGERY WAS DONE BUT THERE WAS NOT FAILURE OF THE IMPLANT." NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186701 X-STOP® INTERSPINOUS SPACER SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SPINE LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention