BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 5.0 MM 10 MM

    MDR report key: 14961009 · Received July 8, 2022

    Report

    Report Number
    0002023141-2022-01758
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    June 9, 2022
    Report Date
    December 15, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024013179
    PMA / PMN Number
    K013494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4). PATIENT AGE IS GIVEN AS IN THEIR TWENTIES. PATIENT WEIGHT IS NOT PROVIDED / UNKNOWN. INITIAL REPORTER¿S TITLE IS NOT PROVIDED / UNKNOWN. ADDITIONAL 510(K) NUMBER IS K962106.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION. THE PRODUCT WAS RETURNED, AND THE REPORTED EVENT WAS UNCONFIRMED FOLLOWING VISUAL EVALUATION AND DRAWING REVIEW. BASED ON THE EVALUATION, DEVICE MALFUNCTION HAS NOT OCCURRED. ADDITIONALLY, 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. 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 EVENTS. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT WAS PERFORMED WITH IN HOUSE SCREW AND THREADED WITH NO ISSUE. 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 AT LOCATION # 19 WAS REMOVED. THE GINGIVAL CUFF CAN'T BE SCREWED. WE TRIED IT WITH A SAMPLE OF THE GINGIVAL CUFF WE HAVE, BUT IT STOPPED HALFWAY AND DID NOT GO ALL THE WAY IN. THE DOCTOR REMOVED THAT IMPLANT AND PLACED ANOTHER PRODUCT.

    Description of Event or Problem · 0

    NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504697 IMPL TWIST MP-1 5.0 MM 10 MM DENTAL IMPLANT DZE ZIMMER DENTAL 1994 63646834 00889024013179

    Patients

    Seq Age Sex Outcome Treatment
    1 Female