BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIN, SCHANZ, 5.5 X 150MM

    MDR report key: 14866073 · Received June 30, 2022

    Report

    Report Number
    1417592-2022-00094
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    June 13, 2022
    Report Date
    June 29, 2022
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY DURING A PROCEDURE THE SCHANZ PIN BROKE INSIDE THE PATIENT. PER THE FACILITY THE BROKEN PIECE WAS REMOVED SUCCESSFULLY AND THE PATIENT IS REPORTED TO BE DOING 'FINE'. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY DURING A PROCEDURE THE SCHANZ PIN BROKE INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2890537 PIN, SCHANZ, 5.5 X 150MM LXH MEDLINE INDUSTRIES LP 10193489094091

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention