BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPRESSION COPING

    MDR report key: 16916062 · Received May 11, 2023

    Report

    Report Number
    0002023141-2023-01317
    Event Type
    Injury
    Date Received
    May 11, 2023
    Date of Event
    April 6, 2023
    Report Date
    October 22, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) UNKNOWN IMPRESSION COPING FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE BUNDLE MOUNT FRACTURED AT THE HEX REGION. SIGNS OF USE, WEAR. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR, STERILIZATION, AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE SUBJECT LOT NUMBER ASSOCIATED WITH THE UNKNOWN IMPRESSION COPING IS NOT AVAILABLE. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO PREVENT THE DISTRIBUTION OF NON-CONFORMING PRODUCT AND ENSURE THE PRODUCT IS WITHIN SPECIFICATIONS. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. IFU REVIEW: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE ¿ PROSTHETICS FOR ZIMMER DENTAL IMPLANT SYSTEMS - 4894 REV. 6 - 08/19; BREAKAGE; PAGE 4. INFORMATION IDENTIFIED: "WARNINGS" & "CONTRAINDICATIONS" BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RMF RM-002P3 REV.10, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION IS EXCESSIVE LOADING ON ABUTMENT/IMPLANT ASSEMBLY. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE REPORTED EVENT (FRACTURE) 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. 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.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED IMPRESSION COPING BROKE IN IMPLANT, HAD TO REMOVE WITH IMPLANT REMOVAL KIT, TOOTH 11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541939 IMPRESSION COPING DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Prefer Not To Disclose Required Intervention