BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABILIT INTRODUCER

    MDR report key: 2123048 · Received November 26, 2008

    Report

    Report Number
    3006396387-2008-00003
    Event Type
    Injury
    Date Received
    November 26, 2008
    Date of Event
    October 27, 2008
    Report Date
    November 26, 2008
    Manufacturer
    DFINE INC.
    Product Code
    DYB
    PMA / PMN Number
    K070351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED FOR INVESTIGATION. PRODUCT WAS DISCARDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY ANOMALY RELATED TO THE COMPLAINT. PRIOR TO RELEASE OF THE LOT, TORQUE AND TENSILE TESTS WERE PERFORMED. TORQUE AND TENSILE TEST RESULTS FOR THE LOT MET ALL SPECIFICATIONS. INVESTIGATION REVEALED THE PHYSICIAN WAS UNABLE TO REINSERT THE INTRODUCER STYLET. THE PHYSICIAN TRIED TO REMOVE THE INTRODUCER AND PLASTIC HANDLE BROKE OFF. PHYSICIAN TRIED TO REMOVE THE WORKING CANNULA USING VICE GRIPS, HOWEVER, ONE PIECE COULD NOT BE REMOVED. (B)(4). PER UPDATED INFO, PT IS DOING FINE. THE PT IS PAIN FREE AND HAS NOT REQUIRED ANY ADD'L SURGERY.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PHYSICIAN TRIED TO REMOVE THE WORKING CANNULA AND IT BROKE. MEDICAL INTERVENTION WAS REQUIRED BUT WAS UNSUCCESSFUL IN REMOVING THE BROKEN CANNULA FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILIT INTRODUCER INTRODUCER DYB DFINE INC. 0951 CSB-0807-09

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention