BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCATOR ABUTMENT 3.4MM(D) X 4MM(H)

    MDR report key: 11672622 · Received April 15, 2021

    Report

    Report Number
    0001038806-2021-00612
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    February 11, 2021
    Report Date
    May 20, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K012911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT REGARDING LOCATOR FRACTURE WAS CONFIRMED. THE REPORTED MLOA004 LOCATOR ABUTMENT INVESTIGATION WAS PERFORMED BY THE SUPPLIER, ZEST ANCHOR INC. BASED ON THE EVALUATION, DEVICE MALFUNCTION HAD OCCURRED. ADDITIONALLY, THERE IS NO EXISTING NON-CONFORMANCE / CAPA / HHE/D / IE / PRODUCT HOLD AGAINST THE REPORTED DEVICE THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENTS. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS WITHIN SPECIFICATIONS AND CONFORMING WHEN IT LEFT ZIMMER BIOMET. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. THEREFORE, THE REPORTED EVENT COULD NOT BE RECREATED. POTENTIAL FAILURE MODES AS PER RISK MANAGEMENT FILES: THE PROBABLE CAUSE FOR THE REPORTED EVENT IS EXCESSIVE TORQUE DURING IMPLANT PLACEMENT. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. RISKS ASSOCIATED WITH LOCATOR FRACTURE ARE OWNED AND WERE REVIEWED BY THE SUPPLIER, ZEST ANCHOR INC. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA/HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. CORRECTIVE ACTIONS WITH LOCATOR FRACTURE ARE OWNED BY THE SUPPLIER, ZEST ANCHOR INC.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW FRACTURED IN THE IMPLANT #11 AND NEEDS TO BE REMOVED. THE SCREW COULD NOT BE REMOVED WITH TOOLS PROVIDED AND IMPLANT WAS PUT TO SLEEP UNTIL CURRENT PLAN FOR APPLIANCE CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570206 LOCATOR ABUTMENT 3.4MM(D) X 4MM(H) DENTAL ABUTMENT DZE BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1