BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE X-STOP® INTERSPINOUS SPACER

    MDR report key: 3927873 · Received July 10, 2014

    Report

    Report Number
    1030489-2014-03223
    Event Type
    Injury
    Date Received
    July 10, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    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. PT AGE: MEAN AGE: (B)(6) YEARS. 22 MEN, 6 WOMEN. (B)(6). (B)(4). 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 SPINOUS PROCESS FRACTURE REPORTED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403801 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 Other