BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.1MM,SBM,10

    MDR report key: 14449657 · Received May 20, 2022

    Report

    Report Number
    0002023141-2022-01238
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 29, 2022
    Report Date
    October 31, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019225
    PMA / PMN Number
    K072589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4) THIS REPORT IS INTENDED TO MODIFY EVENT DATE

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT, B5: DESCRIBE EVENT OR PROBLEM, G3: DATE RECEIVED BY THE MANUFACTURER, H1: TYPE OF REPORT, FOLLOW-UP NUMBER, H2: FOLLOW UP TYPE, H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES,' *H4: DEVICE MANUFACTURE DATE, H6: EVALUATION CODES, H10: ADDITIONAL NARRATIVE. AN IMPLANT WAS NOT RETURNED. SINCE PRODUCT HAS NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION. VIAL WAS RETURNED AND SEAL HAS BEEN BROKEN AND OPENED. NO PRODUCTS INSIDE.PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT® AND TRABECULAR METAL¿ IMPLANTS IFU (B)(4) REV 9 ¿ 10/19. INFORMATION IDENTIFIED: 'DESCRIPTION.' DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1243962). 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. THERE WAS NO INDICATION OF A PACKAGING NC. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1243962) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: INCORRECT COMPONENT QUANTITY. POST MARKET TREND REVIEW: AUG 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 COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN OPENING THE BLISTER, IT WAS EMPTY, NO IMPLANT FOUND. PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.

    Description of Event or Problem · 0

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

    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
    2450504 IMP,TSV,4.1MM,SBM,10 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B10 1243962 00889024019225

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male