BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

    MDR report key: 6201719 · Received December 23, 2016

    Report

    Report Number
    1030489-2016-03497
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Report Date
    November 29, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: KUNOGI JUNICHI, SAKAMOTO RYUJI, MASUDA KAZUHIRO, KAWAMURA NAOHIRO "COMPLICATIONS AND REVISION SURGERY OF MINIMALLY INVASIVE SPINAL SURGERY; COMPLICATIONS AND STRATEGY OF X-STOP FOR LUMBAR SPINAL CANAL STENOSIS" 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 IN ABSTRACT THAT TOTAL OF 133 PATIENTS WITH LUMBAR SPINAL STENOSIS UNDERWENT SURGERY TO IMPLANT INTERSPINOUS PROCESS SPACER FROM 2011 DEC TO 2014 MAR. OUT OF THOSE 133 PATIENTS, ONE PATIENT EXPERIENCED SPACER BACK-OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852446 PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1