BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SP 3.7MM 14M M HEXAGON

    MDR report key: 18889351 · Received March 12, 2024

    Report

    Report Number
    0002023141-2024-00689
    Event Type
    Injury
    Date Received
    March 12, 2024
    Date of Event
    October 7, 2021
    Report Date
    March 11, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024017481
    PMA / PMN Number
    K082639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: PREMARKET IDENTIFICATION: K011245/K002188 A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR INFECTION EVENTS IDENTIFYING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO THE WIDE RANGE OF EXTERNAL (NON-DESIGN/ NON-MANUFACTURING RELATED) FACTORS POTENTIALLY IMPACTING THE STERILITY OF THE IMPLANT AND ITS ENVIRONMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED. H3 OTHER TEXT : SUMMARY INVESTIGATION

    Description of Event or Problem · 0

    DOCTOR REPORTED IMMEDIATE IMPLANTATION WITH LITTLE PRIMARY STABILITY AND INFECTION AT TOOTH SITE 15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029538 IMPL TAPERED SP 3.7MM 14M M HEXAGON DENTAL IMPLANT DZE ZIMMER DENTAL 2020100498 00889024017481

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male