BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM

    MDR report key: 12687519 · Received October 25, 2021

    Report

    Report Number
    0002023141-2021-02992
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 17, 2021
    Report Date
    March 30, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020054
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES'. A IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM (TSVWB11) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED IMPLANT WITH MOUNT. MOUNT NOT ATTACHED TO IMPLANT AND SLIGHT MARKS ON IMPLANT DUE TO THE REMOVAL PROCESS OF DISENGAGING MOUNT BY THE DR. NO MALFUNCTION IDENTIFIED. PRE-EXISTING PATIENT FACTORS, X-RAY, TOOTH LOCATION ARE NOT RELEVANT TO THE REPORTED EVENT. THE LENGTH OF THE DEVICE USAGE IS UNKNOWN. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT®, ADVENT® AND TRABECULAR METAL¿ IMPLANTS 4869 REV 9-10/19. INFORMATION IDENTIFIED: 'CONTRAINDICATIONS' 'WARNINGS' 'CHANGES IN PERFORMANCE' 'ADVERSE EFFECTS' DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1242068). 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: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1242068) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DOES NOT DISENGAGE; RELEASE. POST MARKET TREND REVIEW: JANUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS UNCONFIRMED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER K013227.

    Description of Event or Problem · 1

    IMPOSSIBLE TO UNSCREW THE MOUNT FROM THE IMPLANT DURING THE IMPLANT PLACEMENT. IMPLANT WAS REMOVED. ANOTHER IMPLANT HAS BEEN USED IN ORDER TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592153 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB11 1242068 00889024020054

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male