BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE SURGICAL SUPPLY CO., INC.

    MDR report key: 25209273 · Received May 18, 2026

    Report

    Report Number
    1287163-2026-10002
    Event Type
    Injury
    Date Received
    May 18, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 29, 2026
    Manufacturer
    ACE SURGICAL SUPPLY CO., INC.
    Product Code
    DZE
    UDI-DI
    00614950005222
    PMA / PMN Number
    K103790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THESE RECORDS ARE BEING SUBMITTED FOLLOWING THE COMPLETION OF THE NECESSARY SYSTEM UPDATES TO CORRECTLY REFLECT THE MANUFACTURER INFORMATION. CONFIGURATION AND VALIDATION DOCUMENTATION UPDATES WERE REQUIRED TO ENABLE SUBMISSION OF THE MANUFACTURER, ACE SURGICAL SUPPLY, ALONG WITH THE CONTACT OFFICE INFORMATION FOR BIOHORIZONS. AT THE TIME OF THE INITIAL REPORT, IT WAS NOT COMMUNICATED THAT THE DEVICES WOULD BE RETURNED FOR PROCESSING. ONCE THE PRODUCT WAS RETURNED, IT NECESSITATED THE CONFIGURATION UPDATES AND VALIDATION CHANGES DESCRIBED ABOVE. THESE UPDATES WILL SUPPORT PROPER HANDLING OF FUTURE SUBMISSIONS. THE RECORDS INCLUDED IN THIS SUBMISSION REFLECT THE ORIGINALLY REPORTED DEVICES PROVIDED TO BIOHORIZONS.

    Description of Event or Problem · 0

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401139 ACE SURGICAL SUPPLY CO., INC. DENTAL IMPLANT DZE ACE SURGICAL SUPPLY CO., INC. 304310 21120024 00614950005222

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention