BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABILIT INTRODUCER

    MDR report key: 1416208 · Received July 16, 2009

    Report

    Report Number
    3006396387-2009-00004
    Event Type
    Injury
    Date Received
    July 16, 2009
    Date of Event
    June 19, 2009
    Report Date
    July 16, 2009
    Manufacturer
    DFINE INC.
    Product Code
    ---
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE PATIENT COMPLAINED OF NUMBNESS AFTER THE NUMBNESS AFTER THE VERTEBRAL AUGMENTATION PROCEDURE, THE DEVICE HAD ALREADY BEEN DISCARDED BY THEN. THEREFORE, THE EXACT LOT NUMBER OF THE STABILIT INTRODUCER USED IS UNKNOWN. HOWEVER, IT IS MOST LIKELY ONE OF TWO OPTIONS LISTED BELOW. INTRODUCER LOT#: CSB-0905-05, DOM 05/2009, EXPIRATION DATE: 11/30/2009. A REVIEW OF THE DEVICE HISTORY RECORD FOR BOTH LOTS DID NOT REVEAL ANY ANOMALIES RELATED TO THE COMPLAINT. PRIOR TO RELEASE OF THE LOT, TORQUE, TENSILE, AND DIMENSIONAL INSPECTION TESTS WERE PERFORMED. TORQUE, TENSILE, AND DIMENSIONAL INSPECTION TEST RESULTS FOR THE 2 LOTS MET ALL SPECIFICATIONS. DURING LAMINECTOMY, PERFORMED POST VERTEBRAL AUGMENTATION PROCEDURE, MINOR TRAUMA TO THE SPINAL CORD WAS NOTED AT THE LEVEL THE INTRODUCER WAS INSERTED. THE NUMBNESS ON THE PATIENT'S RIGHT SIDE WAS CONCLUDED TO BE A RESULT OF THE PLACEMENT OF THE INTRODUCER (TOO MEDIALLY) DURING INSERTION THROUGH THE PEDICLE. PHYSICIAN STATED THAT THE PATIENT SHOULD RECOVER FULLY.

    Description of Event or Problem · 1

    PATIENT COMPLAINED OF RIGHT LEG NUMBNESS AFTER THE VERTEBRAL AUGMENTATION PROCEDURE. THE PATIENT WAS OSTEOPOROTIC. LAMINECTOMY WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILIT INTRODUCER INTRODUCER --- DFINE INC. CSD-0903-12

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R