BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1,10,MTX,MG

    MDR report key: 12016691 · Received June 17, 2021

    Report

    Report Number
    0002023141-2021-01558
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    November 18, 2019
    Report Date
    October 22, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019829
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    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. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H6: INVESTIGATION TYPE CODES WERE ADDED: 3331, 4109, 4110, 4111 AND 4114. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 4315. H10: NARRATIVE/DATA WAS UPDATED. ONE IMP,TSV,4.1,10,MTX,MG (TSVT4B10) WAS NOT RETURNED FOR INVESTIGATION. AS A RESULT, VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE INSTRUCTIONS FOR USE (IFU), AND RISK FILE. ALSO, ACCORDING TO THE IFU, PATIENT FACTORS LIKE PRESENCE OF OCCLUSAL ABNORMALITIES OR PARAFUNCTIONAL HABITS (E.G. SEVERE BRUXISM, CLENCHING, OVERLOADING OR GNAWING) MAY CAUSE SCREW LOOSENING, RESTORATION FRACTURE, AND/OR IMPLANT FAILURE. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1240932. 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. COMPLAINT HISTORY REVIEW BY LOT NUMBER (1240932) WAS PERFORMED FOR SIMILAR EVENTS USING KEYWORD IMPLANT FRACTURE, MEDICAL: BONE LOSS AND NO COMPLAINT ABOUT NONCONFORMING PRODUCTS WAS IDENTIFIED. AUGUST POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED DEVICES (TSVT4B10) AND EVENTS (IMPLANT FRACTURE & BONE LOSS). BASED ON THE AVAILABLE INFORMATION DEVICE MALFUNCTION AND THE REPORTED EVENT COULD NOT BE VERIFIED SINCE THE PRODUCT WAS NOT RETURNED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IMPLANT REMOVED BY ORAL SURGEON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME FOR A CONSULT REPORTING PAIN IN THE IMPLANT AREA AT TOOTH SITE # 30. AN X-RAY WAS TAKEN AND IT REVELED A FRACTURED IMPLANT. THE SITE WAS GRAFTED AFTER THE IMPLANT WAS REMOVED (BONE GRAFTING WAS NECESSARY AFTER REMOVAL, IN ORDER TO PLACE NEW IMPLANT. PATIENT WILL RETURN FOR NEW IMPLANT PLACEMENT, UNCOVERING, IMPLANT IMPRESSIONS AND DELIVERY OF CROWN. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914513 IMP,TSV,4.1,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVT4B10 1240932 00889024019829

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention