BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAP ENDO-EXO MEDULLARY SYSTEM

    MDR report key: 23267577 · Received October 10, 2025

    Report

    Report Number
    3000327445-2024-00011
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    November 29, 2024
    Report Date
    October 10, 2025
    Manufacturer
    ORTHOPEDIATRICS CANADA, ULC
    Product Code
    HSB
    PMA / PMN Number
    K111232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A GAP NAIL IMPLANTED IN THE PATIENT BROKE AT THE FIRST DISTAL HOLE SIX WEEKS POST-SURGERY. THE FRACTURE OCCURRED WHILE THE IMPLANT WAS IN SITU, LEADING TO ITS FAILURE. AFTER FURTHER DISCUSSION WITH THE SURGEON AND THE HOSPITAL REPRESENTATIVE, IT WAS DETERMINED THAT THE PATIENT'S BONE DID NOT HEAL AT ALL AND THAT THE PATIENT BEGAN ENGAGING IN WEIGHT-BEARING ACTIVITIES PREMATURELY. AS OUTLINED IN THE DEVICE'S INSTRUCTIONS FOR USE (IFU), DEVICE BREAKAGE OR DAMAGE MAY OCCUR WHEN THE IMPLANT IS SUBJECTED TO INCREASED LOADING ASSOCIATED WITH DELAYED UNION, NON-UNION, OR INCOMPLETE HEALING. THE IFU EXPLICITLY STATES THAT PROPER BONE CONSOLIDATION SHOULD BE CONFIRMED BEFORE RESUMING FULL WEIGHT-BEARING ACTIVITIES. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED ON JANUARY 7, 2025, BUT WAS REJECTED BY CDRH DUE TO AN INCORRECT FEI NUMBER IN THE ESUBMITTER FORM. IT IS NOW RESUBMITTED WITH THE CORRECT FEI (3000327445). CAPA INITIATED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    A GAP NAIL IMPLANTED IN THE PATIENT BROKE AT THE FIRST DISTAL HOLE SIX WEEKS POST-SURGERY. THE FRACTURE OCCURRED WHILE THE IMPLANT WAS IN SITU, LEADING TO ITS FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311159 GAP ENDO-EXO MEDULLARY SYSTEM GAP NAIL HSB ORTHOPEDIATRICS CANADA, ULC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other