BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE X-STOP® INTERSPINOUS SPACER

    MDR report key: 3929979 · Received July 11, 2014

    Report

    Report Number
    1030489-2014-03229
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION : NAOHIRO KAWAMURA, JUNNICHI KUNOKI, KAZUHIRO MASUDA, KENGO FUJII. "POSTERIOR DECOMPRESSION AND STABILIZATION FOR LUMBER SPINAL STENOSIS". 1406-04; S3-1-4. 7/10/2014. (B)(4): UNKNOWN PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ABSTRACT THAT TOTAL OF 28 PATIENTS UNDERWENT AN INTERSPINOUS PROCESS DECOMPRESSION PROCEDURE USING AN INTERSPINOUS SPACER. ALL PATIENTS WERE ASYMPTOMATIC WHILE IN A SITTING POSITION BUT DEVELOPED SYMPTOMS IN THEIR LEGS WHEN STANDING OR WALKING DURING THE PRE-OPERATIVE PERIOD. TREATED LEVELS INCLUDED L4/5 [N=27], L3/4 [N=2]. ACCORDING TO THE ABSTRACT, THERE WAS ONE POSTERIOR IMPLANT DISPLACEMENT REPORTED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407171 THE X-STOP® INTERSPINOUS SPACER PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR