BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONT BLANC

    MDR report key: 13966290 · Received March 31, 2022

    Report

    Report Number
    3010758686-2022-00002
    Event Type
    Injury
    Date Received
    March 31, 2022
    Report Date
    March 31, 2022
    Manufacturer
    SPINEWAY SA
    Product Code
    LXH
    UDI-DI
    03663422603319
    PMA / PMN Number
    K161387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DURING SURGERY A PEDICLE PROBE BROKE, AND THE TIP REMAINED IN THE PATIENT'S BONE. THE MATERIAL OF THE PROBE IS NOT INTENDED TO BE IMPLANTED AND THUS, THE RISK OF SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT FOR A LONG-TERM IN UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872842 MONT BLANC PEDICLE PROBE, THORACIC, STRAIGHT LXH SPINEWAY SA 2171095 03663422603319

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other