BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TWIST MTX 5.0 MM 13 MM

    MDR report key: 14118541 · Received April 15, 2022

    Report

    Report Number
    0002023141-2022-00923
    Event Type
    Injury
    Date Received
    April 15, 2022
    Date of Event
    March 11, 2022
    Report Date
    October 5, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K013494
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL 510(K) NUMBER IS K962106.

    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. ZIMMER BIOMET 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. 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/IE ESCALATION. 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 010363. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. STERILIZATION RECORD ST# (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 010363 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: FUNCTIONAL PERI-IMPLANTITIS. AS DOCUMENTED IN THE SUMMARY INVESTIGATIONS, CONTRIBUTING FACTORS FOR THE REPORTED EVENT LIKELY EXIST OUTSIDE OF ZIMMER BIOMET 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT CAME OUT DUE TO PERI-IMPLANTITIS AT THE SITE WITH EDEMA AND BONE LOSS. TOOTH #4.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1974828 IMPL TWIST MTX 5.0 MM 13 MM DENTAL IMPLANT DZE ZIMMER DENTAL 010363

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention