BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP INTERSPINOUS SPACER SYSTEM

    MDR report key: 5096766 · Received September 23, 2015

    Report

    Report Number
    1030489-2015-02483
    Event Type
    Injury
    Date Received
    September 23, 2015
    Report Date
    August 25, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NQO
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION:KEN SATO, MASATO HONDA, SOUICHI NAKAJIMA, YUUICHI TOUJOU, SINICHIROU YOSHIDA AND YUTAKA YABE; "RESULTS OF TREATING LUMBAR SPINAL CANAL STENOSIS WITH X-STOP". AGE UPON SURGERY WAS 60-77(MEAN:69). THERE WERE 4 MALES AND 1 FEMALE.

    Description of Event or Problem · 1

    THE 5 PATIENTS (6 AFFECTED INTERVERTEBRAL SPACES) WHO UNDERWENT SURGERY WITH INTERSPINOUS VERTEBRAL SPACER IN AND AFTER (B)(6) 2012 WERE STUDIED. POST-OPERATIVE, SPINOUS PROCESS FRACTURE, NUMBNESS, DYSPHASIA WERE CONFIRMED AS COMPLICATION IN ONE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627790 X-STOP INTERSPINOUS SPACER SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Other