BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIREX PLUS KIT

    MDR report key: 3979177 · Received June 2, 2014

    Report

    Report Number
    2090010-2014-00023
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    ISOTIS ORTHOBIOLOGICS, INC
    Product Code
    FMF
    PMA / PMN Number
    K041991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON ATTEMPTED TO USE ASPIREX FOR SPINE SURGERY ON (B)(6) 2014 ON A (B)(6) YEAR OLD FEMALE PATIENT, AND WHEN HE TWISTED THE NEEDLE INTO THE PEDICLE ON THE LEFT SIDE OF L5, THE HANDLE CAME OFF THE DEVICE. HE TRIED A DIFFERENT ASPIREX DEVICE, AND THE SAME HAPPENED WITH THE SECOND NEEDLE ON THE RIGHT SIDE OF S1. THE SURGERY WAS DELAYED BUT THE TIME WAS 'NOT SIGNIFICANT' (A SPECIFIC TIME OF DELAY COULD NOT BE RECALLED) ... A SPARE DEVICE WAS AVAILABLE. THE SURGEON USED DIFFERENT INSTRUMENT TO REMOVE BOTH NEEDLES FROM THE SPINE OF THE PATIENT. THERE WAS NO INJURY TO THE PATIENT ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322201 ASPIREX PLUS KIT ORTHOBIOLOGICS FMF ISOTIS ORTHOBIOLOGICS, INC 29058

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR