BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,MCOL MG,3.7MM,11M

    MDR report key: 9498868 · Received December 19, 2019

    Report

    Report Number
    0002023141-2019-01338
    Event Type
    Malfunction
    Date Received
    December 19, 2019
    Date of Event
    January 7, 2019
    Report Date
    January 20, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K111889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT DATE RECEIVED BY MANUFACTURER FIELD. EVENT WAS REASSESSED DUE TO ADDITIONAL INFORMATION RECEIVED ON 20-NOV-19. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: DATE OF THIS REPORT, CHECKED "FOLLOW-UP", CHECKED FOLLOW-UP TYPE. THE FOLLOWING SECTION HAS BEEN CORRECTED: DATE RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 0

    OUTER BOX AND INNER VIAL FROM IMP,TSV,MCOL MG,3.7MM,11M (TSVMB11) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED THAT VIAL WAS EMPTY AND CONTAIN NO IMPLANT OR OTHER COMPONENTS. THE PACKAGING IS ALREADY OPENED. THE PRODUCT IS NOT NOTED TO HAVE BEEN USED IN A PATIENT. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE PRODUCT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1220619. 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. THE VIAL COMPONENTS WERE CONFIRMED TO BE PRESENT IN ALL PACKAGING INSPECTED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1220619) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. NOVEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (MISSING COMPONENTS) OR PRODUCT (TSVMB11). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT D4: UNIQUE IDENTIFIER (UDI) NUMBER D4: EXPIRATION DATE G4: DATE RECEIVED BY MANUFACTURER G7: CHECKED "FOLLOW-UP" H2: CHECKED FOLLOW-UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER H6: ENTERED EVALUATION CODES H10: ADDED MANUFACTURER NARRATIVE

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT DATE RECEIVED BY MANUFACTURER.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). AGE: NOT PROVIDED. PATIENT WEIGHT: NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED A MISSING IMPLANT (TSVMB11) FROM THE INNER VIAL. EVENT WAS CONFIRMED OCCURRED DURING PROCEDURE AND DOCTOR WAS ABLE TO COMPLETE THAT PROCEDURE USING ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289351 IMP,TSV,MCOL MG,3.7MM,11M DENTAL IMPLANT DZE ZIMMER DENTAL 1220619

    Patients

    Seq Age Sex Outcome Treatment
    1