BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE MINI IMPLANT O-BALL 2.5 MMD X 10 MML

    MDR report key: 12443723 · Received September 8, 2021

    Report

    Report Number
    3011649314-2021-00314
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Report Date
    July 9, 2022
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K100932
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS; THE DHR FOR LOT# 6092164 WAS REVIEWED AND THERE WAS NO EVIDENCE DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. THE PART MET ALL THE CRITERIA CALLED FOR IN THE PRODUCTION ROUTER. STOCK PRODUCT REVIEWED RESULTS; THERE WAS NO STOCK PRODUCT FROM LOT# 6092164 AVAILABLE FOR REVIEW. INVESTIGATION METHODS/RESULTS; THE DEVICE WAS RETURNED, BUT DID NOT TRANSFER TO THE INVESTIGATOR. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE; A ROOT CAUSE FOR THE REPORTED ISSUE CANNOT BE EXPLICITLY DETERMINED. IT IS UNKNOWN IF THE IF THE PRACTITIONER FOLLOWED THE PROPER SURGICAL PROCEDURES FOR THE FINAL INSERTION LISTED IN THE INSTRUCTIONS FOR USE. PROBABLE ROOT CAUSE IS OVER-TORQUEING. PER IFU-4990 REV. 2.0 (INCLUSIVE MINI IMPLANT SYSTEM IFU), THE "SURGICAL PROCEDURES" SECTION STATES: "ALL SURGICAL INSTRUMENTS USED MUST BE IN GOOD CONDITION AND SHOULD BE USED CAREFULLY TO AVOID DAMAGE TO IMPLANTS OR OTHER COMPONENTS. IMPLANTS SHOULD BE PLACED WITH SUFFICIENT STABILITY; HOWEVER, EXCESSIVE INSERTION TORGUE MAY RESULT IN IMPLANT FRACTURE, OR FRACTURE OR NECROSIS OF THE IMPLAINT SITE. THE PROPER SURGICAL PROTOCOL SHOULD BE STRICTLY ADHERED TO." ALSO, PER IFU-4990 REV. 2.0 (INCLUSIVE MINI IMPLANT SYSTEM IFU), THE "FINAL INSERTION" SECTION STATES: "...FOR IMMEDIATE LOADING OF THE IMPLANT, FINAL TORQUE AT SEATING SHOULD BE 30-35 NCM MINIMUM. EXCEEDING 45 NCM TORQUE DURING IMPLANT PLACEMENT IS NOT RECOMMENDED."

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. WHEN THE DEVICE IS RETURNED AN INVESTIGATION WILL BE CARRIED OUT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INCLUSIVE TAPERED IMPLANT FRACTURED AT THE TIME OF PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340147 INCLUSIVE MINI IMPLANT O-BALL 2.5 MMD X 10 MML INCLUSIVE MINI IMPLANT O-BALL DZE PRISMATIK DENTALCRAFT, INC. 70-1068-IMP0004 6092164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown