BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TM 3.7MM MTX,11.5MM

    MDR report key: 16881883 · Received May 5, 2023

    Report

    Report Number
    0002023141-2023-01261
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    October 17, 2022
    Report Date
    May 5, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018877
    PMA / PMN Number
    K132258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4). MULTIPLE MDR REPORTS ARE FILED FOR THIS EVENT. SEE 0002023141-2023-00187-2. A4: PATIENT WEIGHT IS NOT PROVIDED / UNKNOWN. E1: INITIAL REPORTER¿S TITLE AND EMAIL ADDRESS ARE NOT PROVIDED / UNKNOWN. THE PRODUCT WAS RETURNED, AND THE REPORTED EVENT WAS CONFIRMED FOLLOWING VISUAL EVALUATION. BASED ON THE EVALUATION, DEVICE MALFUNCTION HAS OCCURRED. 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 ADVERSE TRENDS OR ACTIONABLE TRENDS FOR THE REPORTED EVENT OR DEVICE. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS WITHIN SPECIFICATIONS AND CONFORMING WHEN IT LEFT ZIMVIE. DHR REVIEW FOR THE LOT HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMVIE. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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 IMPLANT FRACTURED AT THE SAME TIME AS THE SCREW. TOOTH SITE #12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678537 IMP,TM 3.7MM MTX,11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TMMB11 1218659 00889024018877

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male