BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE UNITE

    MDR report key: 23883722 · Received December 23, 2025

    Report

    Report Number
    1417592-2025-00741
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    April 2, 2025
    Report Date
    December 24, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    JDR
    PMA / PMN Number
    K210482
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, THE STAPLE INSERTED ON (B)(6) 2025 FOR A "4TH AND 5TH TMT FUSION" HAS BROKEN AT "APPROXIMATELY 3-4 MONTHS POST-OP". THE CUSTOMER REPORTED THAT THE BROKEN STAPLES WERE EXPLANTED ON (B)(6) 2025. THE CUSTOMER SAID THAT "DELAYED UNIONS AND NON-UNIONS HAVE OCCURRED" RELATED TO THE REPORTED INCIDENT. NO DEMOGRAPHIC INFORMATION WAS GIVEN BUT 0 KG WAS ENTERED INTO THIS MDR DUE TO THE PORTAL NOT ACCEPTING THE MDR WITH THE FIELD LEFT BLANK. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. 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.

    Additional Manufacturer Narrative · 0

    UPDATED G4: 510K- K210482.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, THE STAPLE INSERTED ON (B)(6) 2025 FOR A "4TH AND 5TH TMT FUSION" HAS BROKEN AT "APPROXIMATELY 3-4 MONTHS POST-OP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2532386 MEDLINE UNITE STAPLE,NON-S,REFLEX ULTRA,18 X 18MM JDR MEDLINE INDUSTRIES, LP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other