BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,11.5,MTX,MG

    MDR report key: 19143949 · Received April 19, 2024

    Report

    Report Number
    0002023141-2024-01228
    Event Type
    Injury
    Date Received
    April 19, 2024
    Date of Event
    October 22, 2023
    Report Date
    September 11, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020009
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A4: WEIGHT UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER ¿ K101880. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. ZIMVIE RECEIVED THE REPORTED IMPLANT FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE. IMPLANT FRACTURE IDENTIFIED AT THE COLLAR, AND A BROKEN SCREW WAS FOUND INSIDE OF IT. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1252891. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1252891 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE EXCESSIVE OCCLUSAL FORCES - CUSTOMER ERROR. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR. THE REPORTED EVENT WAS CONFIRMED WITH ALL THE AVAILABLE INFORMATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT RETURNED TO OUR OFFICE ON REFERRAL FROM THEIR RESTORING DENTIST WITH A LOOSE IMPLANT CROWN. ON EXAM, THE NECK OF THE IMPLANT AT TOOTH LOCATION #14 WAS CRACKED. THE IMPLANT WAS REMOVED AND THE SOCKET GRAFTED FOR FUTURE IMPLANT RE-PLACEMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694639 IMP,TSV,4.7,11.5,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1252891 00889024020009

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Required Intervention