BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 3.7MM MTX FULL,10M

    MDR report key: 16974990 · Received May 22, 2023

    Report

    Report Number
    0002023141-2023-01394
    Event Type
    Injury
    Date Received
    May 22, 2023
    Date of Event
    May 8, 2023
    Report Date
    November 15, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018990
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER(B)(4). A1: PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. 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 WAS PERFORMED, A FRACTURE HAS BEEN IDENTIFIED ON THE IMPLANTS BODY. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1241937. 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 1241937 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WERE MISSING OR CONFUSING INSTRUCTIONS FOR USE AND CLINICIAN SELECTS IMPLANT THAT IS UNABLE TO RESIST LONG-TERM OCCLUSAL LOADING. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR. THE FRACTURE HAS BEEN IDENTIFIED ON THE BODY. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE 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 IMPLANT AT TOOTH SITE #29 LOST INTEGRATION AND WAS REMOVED DUE TO A FRACTURE. THE PATIENT CAME IN FOR A TORQUE TEST AND THE IMPLANT WAS BROKEN AND BURIED THE WHOLE TIME.

    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
    760731 IMP TM 3.7MM MTX FULL,10M DENTAL IMPLANT DZE ZIMMER DENTAL TMTB10 1241937 00889024018990

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Prefer Not To Disclose Required Intervention