BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    MDR report key: 13672344 · Received March 4, 2022

    Report

    Report Number
    0002023141-2022-00584
    Event Type
    Injury
    Date Received
    March 4, 2022
    Date of Event
    September 30, 2021
    Report Date
    August 9, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET (B)(4). PATIENT WEIGHT NOT PROVIDED. ADDITIONAL 510(K) NUMBERS ARE K011028 AND K013227.

    Additional Manufacturer Narrative · 0

    ONE (1) IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM (TSVB10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED DRIED BLOOD ATTACHED TO THE IMPLANT, SIGNS OF USE. IMPLANT MATCHED PRINTS WHEN MEASURED USING CALIPER 1831, DUE SEPT 02, 2022. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. A PRE-EXISTING CONDITION NOTED ON THE PER WAS MODERATE BONE DENSITY (TYPE II). THE REPORTED DEVICE WAS LOCATED ON TOOTH # 29 (UNIVERSAL) AND WAS USED FOR APPROXIMATELY 29 DAYS. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. REVIEW OF APPROPRIATE DOCUMENTATION: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT® AND TRABECULAR METAL¿ IMPLANTS 4869 REV 9 ¿ 10/19. INFORMATION IDENTIFIED: CONTRAINDICATIONS, WARNINGS. DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1241362). 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. STERILIZATION RECORD (OP#160) WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1241362) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING . KEYWORDS: ALLERGIC REACTION. POST MARKET TREND REVIEW: JUNE POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (ALLERGIC REACTION) OR PRODUCT (TSVB10). NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO AN ALLERGIC REACTION WITH POOR SOFT TISSUE HEALING. PATIENT WILL NOT RETURN FOR ADDITIONAL APPOINTMENTS.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031465 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB10 1241362 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention