BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,8

    MDR report key: 10350492 · Received July 31, 2020

    Report

    Report Number
    0002023141-2020-01147
    Event Type
    Injury
    Date Received
    July 31, 2020
    Date of Event
    March 12, 2020
    Report Date
    October 19, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    IMP,TSV,4.1MM,SBM,8 (TSV4B8) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF WEAR FROM USE ABOUT THE IMPLANT THREADS AND DRIVE FEATURES. PRODUCT MATCHED PRINT SPECIFICATION WHERE MEASURED. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH SITE 29 (UNIVERSAL). THE IMPLANT WAS USED FOR APPROXIMATELY 6 DAYS. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT (MEDICAL CONDITIONS). DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1231018. 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 WAS PERFORMED FOR THE REPORTED LOT NUMBER (1231018) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. AUGUST POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT (TSV4B8). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS NOT OCCURRED AND THE REPORTED EVENTS WERE NON-VERIFIABLE. BASED ON THE INVESTIGATION AND RISK FILE REVIEW, THE POTENTIAL CAUSE FOR THE REPORTED EVENT IS CUSTOMER ERROR IN CASE PLANNING.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). PATIENT WEIGHT: NOT PROVIDED. INITIAL REPORTER FAX NUMBER: NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT (TSV4B8) WAS REMOVED DUE TO LIP PARESTHESIA AT TOOTH LOCATION 29.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812936 IMP,TSV,4.1MM,SBM,8 DENTAL IMPLANT DZE ZIMMER DENTAL 1231018

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention