BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.7 X 13 IMPLANT

    MDR report key: 10358274 · Received August 3, 2020

    Report

    Report Number
    0001038806-2020-01055
    Event Type
    Injury
    Date Received
    August 3, 2020
    Report Date
    October 16, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER CONFIRMED THE UNK IMPLANT AS TSVTB13 LOT 1223374, ZIMMER IMPLANT. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE WAS FILED UNDER THE INCORRECT MFR NUMBER (0001038806-2020-01055) ON 3 AGO 2020. THEREFORE, THIS REPORT IS BEING FILED UNDER THE CORRECT MFR 0002023141 - 2020 - 01687. AS A RESULT, NO FURTHER MEDWATCH REPORTS WILL BE SUBMITTED. PLEASE REFER TO MFR 0002023141 - 2020 - 01687 FOR DETAILS AND FOLLOW UP SUBMISSIONS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM CUSTOMER CONFIRMING THE UNK IMPLANT AS TSVTB13 LOT 1223374. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE WAS FILED UNDER THE INCORRECT MFR NUMBER 0001038806-2020-01055.

    Additional Manufacturer Narrative · 1

    SUMMARY INVESTIGATION (B)(4). PATIENT ID UNKNOWN. AGE & DOB UNKNOWN. GENDER UNKNOWN. WEIGHT UNKNOWN. ETHNICITY UNKNOWN. EVENT DATE UNKNOWN. IMPLANT CATALOG & LOT # & UDI # UNKNOWN. REPORTERS: TITLE AND LAST NAME UNKNOWN. 510K # UNKNOWN. MANUFACTURER DATE UNKNOWN. 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 THE IMPLANT WAS REMOVED DUE TO AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824128 4.7 X 13 IMPLANT DENTAL IMPLANT DZE BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention