BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 4.7MM MTX FULL, 13

    MDR report key: 9257216 · Received October 30, 2019

    Report

    Report Number
    0002023141-2019-00996
    Event Type
    Injury
    Date Received
    October 30, 2019
    Report Date
    October 30, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019058
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS PREVIOUSLY SUBMITTED UNDER THE INCORRECT MFR 0001038806 - 2019 - 00706 ON 15-JUL-2019. A REASSESSMENT HAS BEEN COMPLETED. ONE IMP TM 4.7 MM MTX FULL, 13 (TMTWB13) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCTS IDENTIFIED WEAR AND DEBRIS WITHIN THE DRIVE FEATURE OF THE IMPLANT AND THE TRABECULAR METAL FEATURES. NO PRE-EXISTING CONDITIONS WAS NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH NUMBER 14 AND USED FOR 20 DAYS. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE PRODUCT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1223137. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE, 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. REVIEW OF THE RAW MATERIALS REPORT OF THE DHRS UNDER OP 10 REVEALED NO NON-CONFORMANCE OR REJECTIONS BASED ON MATERIAL SPECIFICATION. IT IS NOT INDICATED BY THE CUSTOMER THAT THE PATIENT HAD SENSITIVITY TO ANY PARTICULAR METAL TYPE, THEREFORE MATERIAL CHARACTERIZATION WAS NOT REVIEWED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1223137) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. JULY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (ALLERGIC REACTION) OR PRODUCTS (TMTWB13). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS NOT OCCURRED AND THE REPORTED EVENT WAS NON-VERIFIABLE. ZIMMER BIOMET COMPLAINT (B)(4). EVENT DATE: NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER: K113753, K112160.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR SUSPECTED ALLERGIC REACTION AND IMPLANT (TMTWB13) WAS REMOVED. SITE WAS BONE GRAFTED. TOOTH LOCATION 14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051805 IMP TM 4.7MM MTX FULL, 13 DENTAL IMPLANT DZE ZIMMER DENTAL TMTWB13 1223137 00889024019058

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention