BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV, 4.1,11, MTX,MC,M

    MDR report key: 10236687 · Received July 6, 2020

    Report

    Report Number
    0002023141-2020-01019
    Event Type
    Injury
    Date Received
    July 6, 2020
    Report Date
    September 8, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344150
    PMA / PMN Number
    K133339
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED. K133339. 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 · 1

    IT WAS REPORTED THAT IMPLANT AT TOOTH SITE # 6 WAS REMOVED DUE TO INFECTION. PATIENT TO RETURN FOR IMPLANT RE-PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION AND ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697560 IMP,TSV, 4.1,11, MTX,MC,M DENTAL IMPLANT DZE ZIMMER DENTAL TSVMWH11 1224378 00889024344150

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention