BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM

    MDR report key: 9775090 · Received March 2, 2020

    Report

    Report Number
    0002023141-2020-00458
    Event Type
    Malfunction
    Date Received
    March 2, 2020
    Date of Event
    January 28, 2020
    Report Date
    May 8, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM (TSVH11) BOX WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED THE IMPLANT BOX WAS OPENED, AND THAT THE VIAL TAMPER RING IS BROKEN. THE INTERNAL COMPONENTS OF THE VIAL INCLUDE ONLY THE CARRIER. THE IMPLANT, MOUNT, AND COVER SCREW ARE MISSING. THE DEVICE IS NOT INDICATED TO HAVE BEEN USED IN A PATIENT. HOWEVER, THE EXACT DETAILS OF THE DEVICE CONDITION, WHEN RECEIVED BY THE CUSTOMER, ARE UNKNOWN. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT (PACKAGING MALFUNCTION). DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1220758. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER THE 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. A REVIEW OF THE PACKAGE INSPECTION CONFIRMED THAT ALL INSPECTED PACKAGING CONTAINED THE CORRECT QUANTITY AND TYPE OF PART. A COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1220758) FOR A SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. MARCH POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (MISSING COMPONENTS) OR PRODUCT (TSVH11). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G7: CHECKED "FOLLOW-UP".

    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. ADDITIONAL PMA/ 510(K) NUMBER: K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DENTAL IMPLANT (TSVH11) WAS NOT FOUND IN THE PACKAGE. PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236759 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 1220758

    Patients

    Seq Age Sex Outcome Treatment
    1