BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,11.5,MTX,MG

    MDR report key: 19523523 · Received June 12, 2024

    Report

    Report Number
    0002023141-2024-01951
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    April 18, 2024
    Report Date
    June 11, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020009
    PMA / PMN Number
    K101977
    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). A4: PATIENT WEIGHT UNKNOWN/NOT PROVIDED. G4: PREMARKET IDENTIFICATION K101977/K101880. 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.

    Description of Event or Problem · 0

    DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 45 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182618 IMP,TSV,4.7,11.5,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1265954 00889024020009

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male