BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE TAPERED IMPLANT 3.7 MMD X 13 MML X 3.5 MMP

    MDR report key: 9753286 · Received February 26, 2020

    Report

    Report Number
    3011649314-2020-00432
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    October 17, 2019
    Report Date
    March 11, 2021
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K121406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED, BUT DID NOT TRANSFER TO THE INVESTIGATOR. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR REVIEW RESULTS: THE DHR OF IMPLANT LOT# 6040352 WAS REVIEWED AND THERE WAS NO PRODUCT DEFECT OR NON-CONFORMITY REPORTED. THE PART MET ALL THE CRITERIA CALLED FOR IN THE PRODUCTION ROUTER. NOT ABLE TO REVIEW THE DHR OF THE DRIVER SINCE CUSTOMER DID NOT PROVIDE THE DRIVER'S LOT NUMBER. STOCK PRODUCT REVIEWED RESULTS: THERE WAS NO STOCK PRODUCT FROM LOT# 6040352 AVAILABLE FOR REVIEW. NOT ABLE TO REVIEW THE STOCK PRODUCT OF DRIVER SINCE CUSTOMER DID NOT PROVIDE THE LOT NUMBER. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED, BUT DID NOT TRANSFER TO THE INVESTIGATOR. ROOT CAUSE: THE ROOT CAUSE CANNOT BE EXPLICITLY DETERMINED. BOTH IMPLANT AND DRIVER WERE NOT RETURNED FOR INVESTIGATION. THERE WAS NO EVIDENCE FOUND TO INDICATE THAT THE REPORTED ISSUE WAS CAUSED BY THE DRIVER OR IMPLANT. IT WAS ALSO UNKNOWN IF THE CUSTOMER SELECTED THE CORRECT TYPE AND SIZE OF THE DRIVER FOR IMPLANT PLACEMENT.

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS SUBMITTED LATE DUE TO AN UNEXPECTEDLY HIGH VOLUME OF COMPLAINTS FROM AN INTERNATIONAL DISTRIBUTOR ON 01/13/2020. THE FDA WAS MADE AWARE OF THE HIGH VOLUME OF COMPLAINTS BY GLIDEWELL. AN EMAIL RESPONSE WAS RECEIVED FROM THE FDA ON 02/05/2020. THE PATIENT'S RACE AND ETHNICITY WERE NOT PROVIDED. HOWEVER, THE PATIENT'S NATIONALITY IS LISTED AS (B)(6). THE DEVICE HAS NOT BEEN RETURNED. WHEN/IF THE DEVICE IS RETURNED FOR EVALUATION, THE NEW INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLACEMENT OF AN INCLUSIVE IMPLANT FAILED. THE DOCTOR REPORTED THAT ON (B)(6) 2019, THE IMPLANT WAS BEING PLACED AT TOOTH LOCATION #27 (UNIVERSAL). AS THE IMPLANT WAS BEING PLACED, THE IMPLANT DRIVER STUCK TO THE IMPLANT. THE PATIENT'S CURRENT CONDITION IS REPORTED TO BE "FINE". THE PATIENT HAS TYPE III BONE QUALITY, AND NO RELEVANT MEDICAL OR DENTAL HISTORY. THERE WAS NO ABNORMALITY NOTED WITH THE IMPLANT ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218429 INCLUSIVE TAPERED IMPLANT 3.7 MMD X 13 MML X 3.5 MMP INCLUSIVE TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0008 6040352

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR