BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TWIST MP-1 3.75 MM 1 3 MM

    MDR report key: 10258209 · Received July 10, 2020

    Report

    Report Number
    0002023141-2020-01031
    Event Type
    Injury
    Date Received
    July 10, 2020
    Date of Event
    May 1, 2020
    Report Date
    September 30, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K013494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: H6: METHOD CODE WAS ADDED: 3331 AND 4109. H6: RESULTS CODE WAS ADDED: 3252. H6: CONCLUSIONS CODE WAS ADDED: 4307. THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. THE REPORTED CONDITION OF A FRACTURED IMPLANT WAS CONFIRMED. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNIFICANT SIGNS OF WEAR AND DEBRIS ABOUT THE IMPLANT THREADS AND FRACTURING AT THE TINES. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. 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 (B)(4). PATIENT WEIGHT IS NOT PROVIDED / UNKNOWN. INITIAL REPORTER¿S TITLE IS NOT PROVIDED / UNKNOWN. ADDITIONAL 510(K) NUMBER IS K943604.

    Description of Event or Problem · 1

    DOCTOR REPORTS THAT PATIENT PRESENTED WITH IMPLANT 1990 FRACTURED AND THE IMPLANT WAS REMOVED. TOOTH SITE # 28.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722745 IMPL TWIST MP-1 3.75 MM 1 3 MM DENTAL IMPLANT DZE ZIMMER DENTAL 61885514

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention