BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,MCOL MG,4.7MM,11.5MML

    MDR report key: 14716334 · Received June 16, 2022

    Report

    Report Number
    0002023141-2022-01540
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 19, 2022
    Report Date
    November 29, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019782
    PMA / PMN Number
    K111889
    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). PMA/510K: ADDITIONAL 510(K) NUMBER IS K013227.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT PROVIDED AS THE DEVICE WAS IDENTIFIED DURING THE INVESTIGATION PROCESS AS BEING A TSVMWB11 AND NOT A TSVWB11 AS ORIGINALLY REPORTED UNDER MFR #0002023141 - 2022 - 01540. SECTIONS CORRECTED: D1: BRAND NAME OF DEVICE D4: CATALOG NUMBER UPDATED, LOT NUMBER REMAINS UNKNOWN G4: PMA/510(K) NUMBER ARE K111889 AND K101880 SECTIONS UPDATED: B4: DATE OF THIS REPORT G3: DATE ADDITIONAL INFORMATION WAS RECEIVED G6: TYPE OF REPORT AND FOLLOW UP NUMBER H2: FOLLOW UP TYPE H10: MANUFACTURER'S NARRATIVE.

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). ONE IMPLANT WAS RETURNED FOR INVESTIGATION (IMAGE ATTACHED IN COMPLAINT). VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE IMPLANT WITH MINOR SIGNS OF USE.FUNCTIONAL TESTING WAS COMPLETED, AND THE REPORTED EVENT COULD NOT BE RECREATED. THE IMPLANT AND MOUNT WERE ABLE TO ENGAGE AND DISENGAGE PROPERLY. NO PRE-EXISTING CONDITIONS WERE NOTED AND THE TOOTH LOCATION WAS UNKNOWN.THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE - TAPERED SCREW-VENT AND TRABECULAR METAL IMPLANTS, IFU4869 REV 9-10/19. INFORMATION IDENTIFIED: WARNINGS, PRECAUTIONS AND BREAKAGE (PAGES 1 & 2). PER THE APPLICABLE IFU, IT IS STATED THAT IMPROPER TECHNIQUE CAN CAUSE DEVICE FAILURE. DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1252496). 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 WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: 'DOES NOT DISENGAGE/RELEASE'. POST MARKET TRENDING REVIEW: SEPTEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCTS. 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 UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MOUNT WOULD NOT DISENGAGE AT THE TIME OF IMPLANT PLACEMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    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
    1937657 IMP,TSV,MCOL MG,4.7MM,11.5MML DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB11 1253550 00889024019782

    Patients

    Seq Age Sex Outcome Treatment
    1 Male