BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL ABUTMENT SCREW

    MDR report key: 15570975 · Received October 10, 2022

    Report

    Report Number
    0002023141-2022-02539
    Event Type
    Malfunction
    Date Received
    October 10, 2022
    Report Date
    February 10, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4). CONCOMITANT MEDICAL PRODUCTS: TSVMWB11, IMP, TSV, MCOL MG, 4.7MM, 11.5MML, LOT NUMBER: 1223071.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION. THE PRODUCT WAS NOT RETURNED. THEREFORE, THE REPORTED EVENT COULD NOT BE VERIFIED. BASED ON THE EVALUATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED. HOWEVER, THERE IS NO EXISTING NONCONFORMANCE / CAPA / HHE/D / IE / PRODUCT HOLD AGAINST THE REPORTED DEVICE THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. 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 PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS WITHIN SPECIFICATIONS AND CONFORMING WHEN IT LEFT ZIMMER BIOMET. DHR REVIEW AND COMPLAINT HISTORY REVIEW BY LOT NUMBER COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT WITHIN SPECIFICATIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. 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. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMVIE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREW AT TOOTH SITE #31 LOOSENED IN THE PATIENTS MOUTH. GENERAL PRACTITIONER TIGHTENED.

    Description of Event or Problem · 0

    NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2897452 DENTAL ABUTMENT SCREW DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male DENTAL IMPLANT, SEE NARRATIVE IN H10.