BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZONS DENTAL IMPLANT

    MDR report key: 14437859 · Received May 19, 2022

    Report

    Report Number
    1060818-2021-15679
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    October 11, 2021
    Report Date
    November 10, 2021
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS
    Product Code
    DZE
    PMA / PMN Number
    K071638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DETAILS FOR REPORT NUMBER 1060818-2021-15679 WERE PREVIOUSLY SUBMITTED IN REPORT NUMBER 1060818-2021-12025. REPORT NUMBER 1060818-2021-12025 WAS ORIGINALLY REPORTED AS A 2021 3RD QUARTER VOLUNTARY SUMMARY MALFUNCTION REPORT ON 10/31/2021. HOWEVER, DURING THE PREPARATION OF SINGLE MDR EVENTS DATED 10/11/2021, THE REPORT NUMBER ENDING IN 12025 WAS OVERWRITTEN IN ERROR. THE SINGLE MDR EVENT FOR COMPLAINT (B)(4) SHOULD HAVE NOT BEEN ASSIGNED 1060818-2021-12025 BECAUSE 1060818-2021-12025 HAD ALREADY BEEN USED AND TRANSMITTED. . THEREFORE, THIS SUBMISSION OF 1060818-2021-15679 IS TO CORRECT THE DOUBLE USAGE OF 1060818-2021-12025. REPORT NUMBER 1060818-2021-15679 CREATES THE STAND-ALONE MDR EVENT FOR (B)(4) WHICH WILL ALLOW FOR THE CORRECTION TO 1060818-2021-12025 TO OCCUR. MFR REPORT NUMBER 1060818-2021-12025 WILL BE UPDATED TO ITS ORIGINAL STATE FOR THE 2021 3RD QUARTER VOLUNTARY SUMMARY MALFUNCTION REPORT ASSOCIATED A MISALIGNMENT OF THE HEX.

    Description of Event or Problem · 0

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393571 BIOHORIZONS DENTAL IMPLANT DENTAL IMPLANT DZE BIOHORIZONS IMPLANT SYSTEMS TLR4610 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention