BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZONS, INC.

    MDR report key: 20558505 · Received October 29, 2024

    Report

    Report Number
    1060818-2024-07230
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    April 9, 2024
    Report Date
    June 4, 2024
    Manufacturer
    BIOHORIZONS, INC.
    Product Code
    DZE
    UDI-DI
    00847236017163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECORD CONTINUES TO FAIL AT THE ACK3 LEVEL OF SUBMISSION. RECORD FAILS AT THE ACK3 LEVEL. A REVIEW OF THE NEW SYSTEM REVEALED THIS RECORD WAS NOT SUBMITTED. THE SYSTEM HAS BEEN PROVIDING ERRORS DURING SUBMISSION. CORRECTION ACTION ¿ SUBMITTED RECORD ON DAY OF DISCOVERY. ALERT VENDOR OF ANY ERRORS RECEIVED DURING THE SUBMISSION OF THE RECORD FOR FURTHER RESEARCH AND INVESTIGATION. PREVENTATIVE ACTION ¿ RUN REPORT TO ENSURE RECORDS HAVE BEEN TRANSMITTED BY THEIR RESPECTIVE DUE DATE.

    Description of Event or Problem · 0

    IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.

    Description of Event or Problem · 0

    IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923808 BIOHORIZONS, INC. DENTAL IMPLANT DZE BIOHORIZONS, INC. MLW3015Z UNKNOWN 00847236017163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention