BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,6.0,8,MTX,MG

    MDR report key: 17414997 · Received July 28, 2023

    Report

    Report Number
    0002023141-2023-02079
    Event Type
    Injury
    Date Received
    July 28, 2023
    Report Date
    January 10, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019911
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. B5: NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: TYPE OF EVALUATION CODE WAS ADDED: 3331, 4110 H10: NARRATIVE/DATA WAS UPDATED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1243901. 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 1243901 FOR SIMILAR EVENTS AND ONE (1) OTHER COMPLAINT WAS IDENTIFIED (B)(4). INVESTIGATION HAS YET TO BE COMPLETED AND RESULTS ARE UNAVAILABLE AT THIS TIME. 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 EVENT REMAINS 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

    ZIMMER BIOMET COMPLAINT NUMBER CE-(B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. B3: DATE OF EVENT UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER ¿ K101880. 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-CONFORMANCES 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. SUMMARY INVESTIGATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINICIAN OFFICE WITH PAIN, BONE LOSS, AND IMPLANT MOBILITY. THE PATIENT EXPERIENCED PERI-IMPLANTITIS WITH ABSCESS AND PAIN AT IMPLANT TOOTH SITE #3. THEREFORE, THE IMPLANT WAS REMOVED, AND THE SITE WAS GRAFTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1920951 IMP,TSV,6.0,8,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1243901 00889024019911

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention