BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 13MM LENGTH

    MDR report key: 18870990 · Received March 8, 2024

    Report

    Report Number
    0002023141-2024-00653
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    March 21, 2021
    Report Date
    August 11, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024343894
    PMA / PMN Number
    K142082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN/NOT PROVIDED. E1: PHONE NUMBER (B)(6).

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) CT3113, (EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 13MM LENGTH) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE. NO APPARENT DAMAGE / MALFUNCTION WAS IDENTIFIED WITH THE IMPLANT THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENTS. MEASUREMENTS MATCH DRAWING. (B)(4) DUE: (B)(6) 2024. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1230312. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1230312 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿LOSS OF INTEGRATION¿ & "MEDICAL OTHER" THE CUSTOMER DID SUBMIT ONE (1) IMAGE FOR THE REPORTED EVENTS. (SEE ATTACHMENTS TAB AT CE LEVEL) IFU REVIEW: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE ¿ IMPLANTS, ABUTMENTS AND RESTORATIVE COMPONENTS FOR 3.1MMD EZTETIC¿ IMPLANT - 9228 REV.1 ¿ 11/19.INFORMATION IDENTIFIED: "WARNINGS". BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RMF RM-00541-HAZ REV. 4, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE INADEQUATE TREATMENT PLANNING, OR PATIENT FACTORS - CUSTOMER ERROR. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID NOT OCCUR. THE REPORTED EVENTS WERE NON-VERIFIABLE 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. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO NERVE INJURY. LOSS INTEGRATION.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156951 EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 13MM LENGTH DENTAL IMPLANT DZE ZIMMER DENTAL 1230312 00889024343894

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention