BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP, TSV, 4.7, 8,MTX,MC,MG,HA

    MDR report key: 10485144 · Received September 2, 2020

    Report

    Report Number
    0002023141-2020-01348
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    August 6, 2020
    Report Date
    November 19, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344181
    PMA / PMN Number
    K101880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    H6: METHOD CODE WAS ADDED: 3331 AND 4109. H6: RESULTS CODE WAS ADDED: 180. H6: CONCLUSIONS CODE WAS ADDED: 4307. H10: NARRATIVE/DATA WAS UPDATED. THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. THE REPORTED CONDITION OF IMPLANT BODY CANNOT BE REMOVED FROM FIXTURE MOUNT WAS CONFIRMED. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED MINOR SIGNS OF WEAR DUE TO USAGE. FUNCTIONAL TESTING REVEALED THAT THE MOUNT WAS STUCK TO THE IMPLANT AND COULD NOT BE DISENGAGED WITH HAND TOOLS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE REPORTED DEVICE LOT. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THE REPORTED DEVICE LOT FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. K133339.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. TOOTH SITE #15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949242 IMP, TSV, 4.7, 8,MTX,MC,MG,HA DENTAL IMPLANT DZE ZIMMER DENTAL TSVMWH8 1224376 00889024344181

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention