BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOSIS, SPINAL PEDICLE FIXATION

    MDR report key: 9543049 · Received January 3, 2020

    Report

    Report Number
    9543049
    Event Type
    Malfunction
    Date Received
    January 3, 2020
    Date of Event
    December 18, 2019
    Report Date
    December 24, 2019
    Manufacturer
    RELIANCE MEDICAL SYSTEMS, LLC
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TIP OF STRAIGHT PEDICLE PROBE BROKE OFF IN PATIENT BONE, APPROXIMATELY 3MM IN DIAMETER AND APPROXIMATELY 20MM IN LENGTH WAS LEFT IN THE PATIENT BONE. TIP LEFT IN PATIENT PER SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5261 ORTHOSIS, SPINAL PEDICLE FIXATION MNI RELIANCE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 20440 DA