BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90 DEGREE ROD INSERTER SLIM

    MDR report key: 3061580 · Received April 11, 2013

    Report

    Report Number
    2032593-2013-00022
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 11, 2013
    Manufacturer
    SEASPINE, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTER NOTED: "THE SURGEON HAD DIFFICULTY REMOVING THE ROD INSERTER FROM THE ROD DURING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) OF L4-S1 SURGERY AND HAD TO USE A HAMMER TO DISENGAGE THE INSERTER. THERE WAS NO PATIENT INJURY AND THE SURGERY WAS DELAYED FOR 5 MINUTES DUE TO THIS ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157001 90 DEGREE ROD INSERTER SLIM SPINAL INSTRUMENTS FIXED LXH SEASPINE, INC. M013301B

    Patients

    Seq Age Sex Outcome Treatment
    1