BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP TM 4.1MM MTX FULL, 11.5MM

    MDR report key: 10554014 · Received September 18, 2020

    Report

    Report Number
    0002023141-2020-01455
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Report Date
    November 23, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K132258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TRABECULAR METAL DENTAL IMPLANT (TMT4B11) WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, VISUAL EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION WAS PERFORMED USING APPLICABLE INSTRUCTIONS FOR USE AND RISK FILES. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS NOT RETURNED. NO PRE-EXISTING CONDITIONS WERE REPORTED. THE REPORTED DEVICE HAD BEEN PLACED ON AN UNKNOWN TOOTH LOCATION FOR AN UNKNOWN AMOUNT OF TIME. X-RAY/PICTURE IMAGE WAS NOT PROVIDED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (63661610). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURES. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WERE NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (63661610) AND NO OTHER COMPLAINTS ABOUT NONCONFORMING PRODUCTS WERE IDENTIFIED. SEPTEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION AND THE REPORTED EVENT COULD NOT BE VERIFIED SINCE THE PRODUCT WAS NOT RETURNED AND NO PICTORIAL EVIDENCE WAS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT WEIGHT: NOT PROVIDED. EVENT DATE: NOT PROVIDED. INITIAL REPORTER EMAIL ADDRESS, FAX NUMBER: NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER: K113753, K112160.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERNAL HEX CONNECTION OF THE IMPLANT (TMT4B11) SEEMS TO BE DAMAGED BY AN ABUTMENT SCREW. DOCTOR REQUESTED A THREAD TAP TOOL TO SOLVE THE ISSUE. IMPLANT REMAINS IMPLANTED, NO INJURY HAS BEEN REPORTED AT THE TIME OF THIS REPORT. TOOTH LOCATION 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017984 IMP TM 4.1MM MTX FULL, 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 63661610

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR