BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-STOP INTERSPINOUS SPACER SYSTEM

    MDR report key: 2962468 · Received February 14, 2013

    Report

    Report Number
    1030489-2013-00501
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 10, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: MAGAN NIELSEN. "X-STOP SURGICAL IMPLANT FOR THE TREATMENT OF LUMBAR SPINAL STENOSIS: CLINICAL PRACTICE RECOMMENDATIONS FOR NEUROSURGICAL NURSE PRACTITIONERS." JOURNAL OF NEUROSCIENCE NURSING 2013; VOLUME 45, NUMBER 1, PAGES 44-51. DATE OF EVENT IS UNKNOWN. (B)(6). (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.

    Description of Event or Problem · 1

    AN ARTICLE DESCRIBES THE USE OF A NEWER, LESS-INVASIVE SURGICAL TECHNIQUE VIA AN INTERSPINOUS SPACER SYSTEM TO TREAT NEUROGENIC INTE RMITTENT CLAUDICATION (NIC) BECAUSE OF LUMBAR SPINAL STENOSIS PROVIDES CLINICAL PRACTICE RECOMMENDATIONS FOR NEUROSURGICAL NURSE PRACTITIONERS. IT WAS REPORTED IN THIS ARTICLE THAT "FOUR PATIENTS (6%) OUT OF 69 HAD DEVICE DISLODGEMENT". NO OTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64936 X-STOP INTERSPINOUS SPACER SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1