BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90 DEGREE ROD INSERTER SLIM

    MDR report key: 3061579 · Received April 11, 2013

    Report

    Report Number
    2032593-2013-00023
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 11, 2013
    Manufacturer
    SEASPINE, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BROKE DURING A "MIS" SURGERY. IT OCCURRED DURING ROD INTRODUCTION. THERE WAS NO PATIENT HARM/INJURY. THERE WAS NO MAJOR DELAY IN SURGERY. THE MEDICAL STAFF FINISHED THE SURGERY USING ROD GRASPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155548 90 DEGREE ROD INSERTER SLIM SPINAL INSTRUMENTS-FIXED LXH SEASPINE, INC. M013301B

    Patients

    Seq Age Sex Outcome Treatment
    1