BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,6.0,10,MTX,MG

    MDR report key: 20906891 · Received December 11, 2024

    Report

    Report Number
    0002023141-2024-03999
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    November 3, 2024
    Report Date
    March 31, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019874
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PERI-IMPLANTITIS IS AN INFECTIOUS DISEASE THAT CAUSES INFLAMMATION OF THE GUM AND THE BONE STRUCTURE AROUND A DENTAL IMPLANT. CHRONIC INFLAMMATION CAUSES BONE LOSS, WHICH CAN LEAD TO IMPLANT FAILURE THUS ITS REMOVAL. INVESTIGATIONS PERFORMED FOR HUNDREDS OF EVENTS WHERE EITHER OF THESE CONDITIONS, INFECTION, OR BONE LOSS, OR BOTH, HAVE BEEN REPORTED, HAVE CONCLUDED THAT THE LIKELY CAUSE(S) FOR THE IMPLANT FAILURE IN RELATION TO THESE CONDITIONS ARE EXTERNAL FACTORS. THOSE INCLUDE MEDICAL CONDITIONS (E.G., DIABETES, BRUXISM, ETC.), PATIENT HABITS (E.G., SMOKING, BAD ORAL HYGIENE ROUTINE) AND USER ERROR (E.G., SURGICAL TECHNIQUE). THERE HAS NOT BEEN ANY INSTANCE WHERE EITHER INFECTION AND/OR BONE LOSS, AND WHEN RIGHT CONDITIONS PREVAIL AND LED TO PERI-IMPLANTITIS WHETHER REPORTED OR NOT ALONG WITH THE OTHER TWO, HAVE RESULTED FROM A MANUFACTURING OR DESIGN DEFECT. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO INFECTION AND RESULT IN BONE LOSS OCCURRING AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THE ANALYSIS AND RESULT OF INVESTIGATIONS AND THE ANALYSIS OF PROBABILITY PREVIOUSLY DESCRIBED ARE CONTAINED IN THE SUMMARY INVESTIGATION REPORTS PERFORMED FOR BONE LOSS AND INFECTION, WHICH ARE ATTACHED. ADDITIONALLY, ALL DEVICE HISTORY RECORD REVIEWS VERIFIED THAT EACH IMPLANT WAS STERILIZED PER PROCEDURE FOR EVERY DEVICE. ALL COMPLAINT DATA USED FOR THE SUMMARY INVESTIGATION WAS FOUND TO BE CONFORMING AND DID NOT MEET CAPA/HHE/D/ OR ANY FURTHER ESCALATIONS. THEREFORE, THERE WERE NO COMPLAINTS WHICH CONFIRMED A MANUFACTURING OR DESIGN RELATED ISSUE THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1250935. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. STERILIZATION RECORD (B)(4) WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1250935 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL : MEDICAL : PERI-IMPLANTITIS¿. AS DOCUMENTED IN THE SUMMARY INVESTIGATIONS, CONTRIBUTING FACTORS FOR THE REPORTED EVENT LIKELY EXIST OUTSIDE OF ZIMVIE CONTROL, INCLUDING THOSE RELATED TO PATIENT BIOLOGICAL FACTORS/CONDITION AND SURGICAL TECHNIQUE. BASED ON THE SUMMARY INVESTIGATIONS, NO MALFUNCTION OCCURRED UPON INVESTIGATION. THE REPORTED EVENTS REMAIN NON-VERIFIABLE AS THEY ARE A MEDICAL CONDITION. MONTHLY TRENDING TO DATE HAS NOT IDENTIFIED ANY STATISTICAL TRIGGERS SUGGESTING POTENTIAL DESIGN OR MANUFACTURING RELATED ISSUES. PREVIOUSLY COMPLETED INVESTIGATIONS FOR INFECTION, BONE LOSS, AND/OR PERI-IMPLANTITIS 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. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER: (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER K101880.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #UNK WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT (B)(6) PLACED IN GOOD BONE AT TOOTH #18 SITE ON (B)(6) 2022. BELLATEK (B)(6) PLACED AFTER HEALING AND UNCOVERING IMPLANT ON (B)(6) 2023. ITERO SCAN FOR IMPLANT RESTORATION PERFORMED (B)(6) 2023. CUSTOM ABUTMENT AND CROWN SEATED (B)(6) 2023 AND SCREW WAS TORQUED TO ZIMMER/LAB SPECIFICATIONS. WORKFLOW WAS ENTIRELY ZIMMER. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2428422 IMP,TSV,6.0,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1250935 00889024019874

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention