BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

    MDR report key: 15545420 · Received October 5, 2022

    Report

    Report Number
    0002023141-2022-02509
    Event Type
    Malfunction
    Date Received
    October 5, 2022
    Date of Event
    September 27, 2022
    Report Date
    February 28, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019522
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER IS (B)(4). ADDITIONAL PMA/510(K) NUMBERS ARE K011028 AND K013227.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES.' TWO EMPTY PACKAGING WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PACKAGING IDENTIFIED THEY WERE ALREADY OPEN. THE OUTER VIALS TAMPER SEALS WERE SEEN BROKEN.THE COOB IS NON-VERIFIABLE.FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. PRE-EXISTING PATIENT FACTORS, X-RAY, TOOTH LOCATIONS ARE NOT RELEVANT TO THE REPORTED EVENT. THE CUSTOMER DID PROVIDE ONE PICTURE. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: 4869 REV. 9 -10/19; PRODUCT PACKAGING; (PAGES 2-3.) DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBERS (1255374 & 1250068). 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, WERE NOTED AS PART OF THE DHR. LOT NUMBERS WERE INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. UPON REVIEW OF THE DHRS, PACKAGING IMAGES HAVE BEEN ATTACHED TO FURTHER VERIFY THE CONFORMANCE OF THE PACKAGING FOR THE REPORTED DEVICES. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBERS (1255374 & 1250068) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: 'INCORRECT COMPONENT QUANTITY.' POST MARKET TRENDING REVIEW: DECEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (INCORRECT COMPONENT QUANTITY) OR PRODUCT (TSVB13). NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, THE PACKAGING MALFUNCTION COULD NOT BE VERIFIED, AND THE REPORTED EVENT WAS NON-VERIFIABLE. THE CIRCUMSTANCES OF THE DEVICE DELIVERY COULD NOT BE RECREATED. ADDITIONALLY, THE ALLEGED COOB COULD NOT BE VERIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS MISSING FROM THE PACKAGING AT THE TIME OF IMPLANT PLACEMENT. PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531135 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB13 1250068 00889024019522

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male