BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAP ENDO-EXO MEDULLARY SYSTEM

    MDR report key: 17426748 · Received July 31, 2023

    Report

    Report Number
    3000327445-2023-00004
    Event Type
    Injury
    Date Received
    July 31, 2023
    Report Date
    May 26, 2026
    Manufacturer
    PEGA MEDICAL, INC.
    Product Code
    HSB
    PMA / PMN Number
    K111232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A COMPANY REPRESENTATIVE REPORTED THAT A GAP NAIL WAS FOUND BROKEN IN A 19-YEAR-OLD BRITTLE BONE PATIENT 3 WEEKS AFTER IMPLANTATION. THE NAIL WAS SUCCESSFULLY REMOVED AND REPLACED BY THE IMPLANT OF ANOTHER SYSTEM. THE COMPANY REPRESENTATIVE WAS CONTACTED FOR MORE INFORMATION FOR FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566525 GAP ENDO-EXO MEDULLARY SYSTEM GAP NAIL HSB PEGA MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1