BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,11.5,MTX,MG

    MDR report key: 15653470 · Received October 21, 2022

    Report

    Report Number
    0002023141-2022-02667
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    September 14, 2022
    Report Date
    February 24, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019935
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: H6: TYPE OF INVESTIGATION CODE WAS ADDED: 3331, 4109, 4111. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 4310. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1253854. 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. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE 1253854 DATING BACK TO 12 MONTHS FROM THE COMPLAINT NOTIFICATION DATE. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED DEVICE RELATED TO THE REPORTED EVENT. AS DOCUMENTED IN THE SUMMARY INVESTIGATION, CONTRIBUTING FACTORS FOR THE REPORTED EVENT LIKELY EXIST OUTSIDE OF ZIMMER BIOMET 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2558089 IMP,TSV,3.7,11.5,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTB11 1253854 00889024019935

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention