BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.1MM,SBM,8

    MDR report key: 10360749 · Received August 4, 2020

    Report

    Report Number
    0002023141-2020-01170
    Event Type
    Malfunction
    Date Received
    August 4, 2020
    Date of Event
    June 23, 2020
    Report Date
    October 29, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019263
    PMA / PMN Number
    K072589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE TAPERED SCREW-VENT IMPLANT (TSV4B8) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF WEAR AROUND THE INTERNAL HEX DUE TO USAGE. FUNCTIONAL TESTING WAS PERFORMED USING AN APPLICABLE IN-HOUSE ABUTMENT. THE DEVICE FAILED TO FULLY ASSEMBLE WITH THE ABUTMENT. PRE-EXISTING CONDITION NOTED ON THE PER WAS HIGH BONE DENSITY ¿ TYPE I. THE DEVICE WAS BEING PLACED ON TOOTH # 36 (FDI) WHEN THE INCIDENT OCCURRED. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE LOT (1221590) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE LOT (1221590) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT ABOUT NONCONFORMING PRODUCTS WERE IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND FUNCTIONAL TESTING, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    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). WEIGHT UNKNOWN / NOT PROVIDED. FIRST/GIVEN NAME: UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT HEX CONNECTION WAS DAMAGED DURING IMPLANT PLACEMENT, DOCTOR REMOVED THE IMPLANT AND PLACED ANOTHER ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829343 IMP,TSV,4.1MM,SBM,8 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B8 1221590 00889024019263

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR