BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NANOTITE TM CERTAIN PREVAIL IMPLANT 4/5/4 X 15MM

    MDR report key: 18257589 · Received December 4, 2023

    Report

    Report Number
    0001038806-2023-02351
    Event Type
    Injury
    Date Received
    December 4, 2023
    Report Date
    May 9, 2024
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K051461
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 895615. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 895615 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. AS DOCUMENTED IN THE SUMMARY INVESTIGATION, CONTRIBUTING FACTORS FOR THE REPORTED EVENT LIKELY EXIST OUTSIDE OF ZIMVIE CONTROL, INCLUDING THOSE RELATED TO MEDICAL CONDITIONS / PATIENT HABITS AND SURGICAL TECHNIQUE. BASED ON THE SUMMARY INVESTIGATION, NO MALFUNCTION OCCURRED UPON INVESTIGATION AND NO ASSOCIATION BETWEEN THE DENTAL IMPLANT AND BONE LOSS WAS FOUND THAT CAN EXPLAIN THESE EVENTS. THEREFORE, THE REPORTED EVENT REMAINS NON-VERIFIABLE AS IT IS A MEDICAL CONDITION. MONTHLY TRENDING TO DATE HAS NOT IDENTIFIED ANY STATISTICAL TRIGGERS SUGGESTING POTENTIAL DESIGN OR MANUFACTURING RELATED ISSUES. PREVIOUSLY COMPLETED INVESTIGATIONS FOR BONE LOSS PROBLEMS REPORTED IN ASSOCIATION WITH IMPLANT FAILURE HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES IMPACTING THE MANUFACTURING AND STERILIZATION PROCESSES. THEREFORE, ESCALATION TO CAPA IS NOT REQUIRED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). G4: ADDITIONAL PMA/510(K) NUMBER ¿ K051461. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR BONE LOSS EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. PREVIOUSLY COMPLETED INVESTIGATIONS FOR BONE LOSS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO BONE LOSS AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NON-EXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #9 WAS REMOVED DUE TO BONE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064956 NANOTITE TM CERTAIN PREVAIL IMPLANT 4/5/4 X 15MM DENTAL IMPLANT DZE BIOMET 3I 895615

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention