BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABILIT INTRODUCER

    MDR report key: 5517802 · Received March 22, 2016

    Report

    Report Number
    3006396387-2016-00002
    Event Type
    Injury
    Date Received
    March 22, 2016
    Report Date
    February 25, 2016
    Manufacturer
    DFINE INCORPORATED
    Product Code
    KZH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT REPORTED WAS FROM A CASE STUDY AND PUBLISHED IN JOURNAL OF NEUROINTERVENTIONAL SURGERY BY ANGELIKA KOSSE, JONATHAN PISHOI NAKHLA, REZA YASSARI, APOLONIA ELIZABETH ABRAMOWICZ AND ALLAN BROOK. CORRESPONDENCE TO DR. J P NAKHLA, DEPARTMENT OF NEUROLOGICAL SURGERY, MONTEFIORE MEDICAL CENTER, BRONX, NY 10467, USA. PUBLISHED WITH PERMISSION FROM BMJ CASE REPORTS, PUBLISHED 18 FEBRUARY 2016; DO: 10.1136/BCR-2015-012180. NO DEVICE WAS RETURNED FOR INVESTIGATION AND ANALYSIS.

    Description of Event or Problem · 1

    A CASE STUDY WAS PUBLISHED IN JOURNAL OF NEUROINTERVENTIONAL SURGERY ON LINE 24 FEB 2016. THE AWARENESS DATE OF THE ARTICLE WAS ON 25 FEB2016. CITATION: RETAINED NEEDLE AFTER CEMENT INJECTION DURING VERTEBRAL AUGMENTATION AND ITS MANAGEMENT STRATEGY. KOSSE A, NAKHLA JP, YASSARI R, ABRAMOWICZ AE, BROOK A. J NEUROINTERV SURG. 2016 FEB 24. PII: NEURINTSURG-2015-012180.REP. DOI: 10.1136/NEURINTSURG-2015-012180.REP. [EPUB AHEAD OF PRINT] PMID: 26911334). THE CASE REPORT DESCRIBES A THREE LEVEL VERTEBRAL AUGEMENTATION PROCEDURE USING THE STABILIT VERTEBRAL AUGMENTATION SYSTEM IN A MYELOMA PATIENT WITH NUMEROUS PATHOLOGIC VERTEBRAL COMPRESSION FRACTURES IN WHICH ONE OF THE THREE DFINE INTRODUCERS WAS NOT ABLE TO BE REMOVED PERCUTANEOUSLY. THE INTRODUCER ROTATED WITH A BOLUS OF CEMENT ADHERED TO THE DISTAL END PREVENTING IT FROM BEING WITHDRAWN FROM THE VERTEBRA THROUGH THE PEDICLE. THE INTRODUCER THAT WAS UNABLE TO BE REMOVED HAD BEEN LEFT IN THE PATIENT FOR AN EXTENDED PERIOD OF TIME WITHOUT ANY MOVEMENT OR ROTATION. AFTER SIGNIFICANT MANIPULATION OF THE NEEDLE AND ATTEMPTS TO USE ADDITIONAL NON-DFINE NEEDLES (VIA AN EXTRAPEDICULAR APPROACH) TO DISLODGE THE INTRODUCER FROM THE CEMENT TO WHICH IT WAS ADHERED, THE PATIENT WAS TRANSFERRED TO SURGERY WHERE A SMALL CUTDOWN WAS PERFORMED ALLOWING THE INTRODUCER TO BE CUT FLUSH AT THE ENTRY POINT INTO THE PEDICLE RESULTING IN NO METAL BEING EXPOSED BEYOND THE PEDICLE. THE PAPER REPORTED THAT THE PATEINT RECOVERED WITHOUT COMPLICATIONS AND THE PATEINT MADE AN UNEVENTFUL RECOVERY. THIS WAS CONFIRMED IN A PHONE CONVERSATION WITH THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173498 STABILIT INTRODUCER NEEDLE INTRODUCER KZH DFINE INCORPORATED UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention