BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,MCOL MG,3.7MM,11.5MML

    MDR report key: 15160382 · Received August 3, 2022

    Report

    Report Number
    0002023141-2022-01950
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 13, 2022
    Report Date
    January 5, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019737
    PMA / PMN Number
    K111889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0002023141-2022-01949-1. THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. H6: INVESTIGATION TYPE CODES WERE ADDED: 3331, 4109, 4110 AND 4111. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 4315. TWO (2) IMP,TSV,MCOL MG,3.7MM,11.5MML (TSVMB11) WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE INNER VIALS DID NOT CONTAIN THE INNER IMPLANT CONTAINERS, NOR THE IMPLANTS AND COMPONENTS - VIALS WERE EMPTY. THE VIAL LIDS WERE PREVIOUSLY BROKEN BY THE CUSTOMER - EVENT/COOB ARE UNVERIFIABLE. BASED ON THE EVALUATION, THE REPORTED PACKAGING MALFUNCTION COULD NOT BE VERIFIED. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. BASED ON THE AVAILABLE INFORMATION, THE DEVICE WAS WITHIN SPECIFICATION AND LIKELY CONFORMING WHEN IT LEFT ZIMVIE. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1250073). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1250073) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. THEREFORE, THE REPORTED EVENT COULD NOT BE RECREATED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE INVESTIGATION AND RISK REVIEW, THE MOST LIKELY CAUSE DETERMINED FROM THE INVESTIGATION IS IMPROPER HANDLING OF DEVICE/PACKAGING OUTSIDE OF ZIMVIE CONTROLS. 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 DURING A PROCEDURE, THE DOCTOR FOUND THE IMPLANT VIAL EMPTY WITHOUT AN IMPLANT INSIDE. PROCEDURE WAS ABLE TO BE COMPLETED USING ANOTHER IMPLANT THE DOCTOR HAD IN STOCK.

    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
    2032509 IMP,TSV,MCOL MG,3.7MM,11.5MML DENTAL IMPLANT DZE ZIMMER DENTAL TSVMB11 1250073 00889024019737

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose