BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM

    MDR report key: 11868092 · Received May 22, 2021

    Report

    Report Number
    0002023141-2021-01370
    Event Type
    Injury
    Date Received
    May 22, 2021
    Date of Event
    March 4, 2021
    Report Date
    September 22, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019577
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4) DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1232150). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1232150) FOR SIMILAR CATEGORY MEDICAL: INFECTION THROUGH THE MANUFACTURERS INTERNAL SYSTEM AND NO OTHER COMPLAINT WAS IDENTIFIED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). PATIENT WEIGHT: NOT PROVIDED. FAX NUMBER: NOT PROVIDED. PMA/510(K) NUMBER: ADDITIONAL NUMBER: K013227. 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 IMPLANT AT TOOTH LOCATION # 29 WAS REMOVED DUE TO INFECTION, ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764547 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVH11 1232150 00889024019577

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention