BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 4.7MM MTX FULL, 10

    MDR report key: 20567076 · Received October 30, 2024

    Report

    Report Number
    0002023141-2024-03472
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    September 20, 2024
    Report Date
    March 9, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019034
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: PMA/510(K) NUMBER. K132258, K11375, K112160. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR PERI-IMPLANTITIS 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 THESE EVENTS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCE'S AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF A MANUFACTURING OR DESIGN DEFECT THAT MIGHT LEAD TO PERI-IMPLANTITIS OCCURRING AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WAS RETURNED. DEVICE MALFUNCTION HAS NOT OCCURRED 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 1254291. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. STERILIZATION RECORD OP# (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 1254291 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿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.

    Description of Event or Problem · 0

    PER INDICATED: PERI-IMPLANTITIS. BONE LOSS. LOOSENING. THE PATIENT WAS RECEIVED 5 IMPLANT, PLACEMENT, 2 STAGED PROCEDURES. AFTER 8 MONTHS, THE PATIENTS CAME BACK FOR THE IMPRESSION PHRASE. SYMPTOMS AS A RESULT OF THE EVENT: NONE. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. ADDITIONAL APPOINTMENT REQUIRED: NO. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE? NO.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964765 IMP TM 4.7MM MTX FULL, 10 DENTAL IMPLANT DZE ZIMMER DENTAL 1254291 00889024019034

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention