BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,10

    MDR report key: 16014475 · Received December 20, 2022

    Report

    Report Number
    0002023141-2022-03173
    Event Type
    Injury
    Date Received
    December 20, 2022
    Report Date
    April 18, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019225
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. D9: DATE RETURNED TO MANUFACTURER WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: TYPE OF INVESTIGATION CODES WERE UPDATED: 3331, 4109, 4110, 4111. H6: INVESTIGATION FINDINGS CODE WAS UPDATED: 3252. H6: INVESTIGATION CONCLUSION CODE WAS UPDATED: 4307. H10: NARRATIVE/DATA WAS UPDATED. ONE (1) IMP,TSV,4.1MM,SBM,10 (TSV4B10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE IMPLANT WITH SIGNS OF USE, APPARENT BONE / TISSUE ATTACHED TO EXTERNAL THREADS. THE IMPLANT WAS FRACTURED AROUND THE COLLAR REGION. BASED ON THE EVALUATION, THE DEVICE MALFUNCTION HAS OCCURRED. HOWEVER, THERE IS NO EXISTING NONCONFORMANCE/CAPA/HHE/D/IE/PRODUCT HOLDS AGAINST THE REPORTED DEVICES THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENTS. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS OR DEVICES. ZIMVIE 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 LIKELY CONFORMING WHEN IT LEFT ZIMVIE. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1221740). 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 (1221740) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THE REPORTED EVENTS COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENTS, AND THE COMPLAINT IS RELATED TO THE FUNCTIONAL PERFORMANCE OF THE DEVICES. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE INVESTIGATION, IFU AND RISK FILE REVIEW, THE MOST LIKELY CAUSE DETERMINED FROM THE INVESTIGATION ARE PATIENT FACTORS/PARA-FUNCTIONAL HABITS OVER THE LENGTH OF THE IMPLANTATION PERIOD. NO FURTHER INVESTIGATION AND NO 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 THE IMPLANT ON TOOTH #19 WAS REMOVED DUE TO A FRACTURE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION WAS RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2523207 IMP,TSV,4.1MM,SBM,10 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B10 1221740 00889024019225

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention