BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAUMAN INCLUSIVE INSERTS

    MDR report key: 10683694 · Received October 15, 2020

    Report

    Report Number
    3011649314-2020-00680
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Report Date
    October 20, 2021
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: LOT NUMBER WAS NOT PROVIDED - DHR COULD NOT BE REVIEWED. STOCK PRODUCT REVIEWED RESULTS : LOT NUMBER WAS NOT PROVIDED - STOCK PRODUCT COULD NOT BE REVIEWED. INVESTIGATION METHODS/RESULTS : DEVICE WAS NOT RETURNED FOR INVESTIGATION. ROOT CAUSE : A ROOT CAUSE FOR THE REPORTED ISSUE CANNOT BE EXPLICITLY DETERMINED. IT IS UNKNOWN IF THE PROVIDER IS REFERRING TO THE ABUTMENT OR SCREW AS "INSERT". ADDITIONALLY, IT IS UNKNOWN IF THE PRACTITIONER FOLLOWED THE PROPER DELIVERY PROTOCOLS FOR THE FINAL RESTORATION LISTED IN THE INSTRUCTIONS FOR USE. IT IS ALSO UNKNOWN IF THE APPROPRIATE ABUTMENT WAS USED FOR THE REGION OF THE MOUTH. PROBABLE ROOT CAUSE IS OVER-TORQUING, CROSS THREADING, OR THE ABUTMENT NOT BEING ADEQUATELY SECURED. PER IFU 4849 REV. 4.0 (INCLUSIVE TAPERED IMPLANTS IFU), THE "ADVERSE EVENTS" SECTION STATES: THE FOLLOWING ADVERSE EFFECTS HAVE BEEN OBSERVED WHEN USING PROSTHETIC COMPONENTS AND ACCESSORIES: · THE ABUTMENT SCREW HAS FRACTURED DUE TO APPLICATION OF EXCESSIVE TORQUE. · THE ABUTMENT IS NOT ADEQUATELY SECURED DUE TO INADEQUATE APPLICATION OF TORQUE. PER IFU 4849 REV. 4.0 (INCLUSIVE TAPERED IMPLANTS IFU), THE "DELIVER THE FINAL RESTORATION" SECTION STATES: "SEAT THE TITANIUM ABUTMENT OR SCREW-RETAINED HYBRID RESTORATION COMPLETELY INTO THE IMPLANT, MAKING SURE THAT THE ANTI-ROTATIONAL FEATURES OF THE CONNECTION INTERFACE ARE FULLY ENGAGED AND THE CONTOURS OF THE SCULPTED EMERGENCE PROFILE ARE ESTHETICALLY ORIENTED. INSERT THE APPROPRIATE COMPATIBLE ABUTMENT SCREW INTO THE SCREW ACCESS HOLE AND HAND-TIGHTEN USING THE APPROPRIATE DRIVER. IT IS STRONGLY RECOMMENDED THAT A RADIOGRAPH OF THE CONNECTION SITE BE TAKEN TO CONFIRM COMPLETE SEATING OF THE ABUTMENT OR HYBRID RESTORATION BEFORE PROCEEDING. USING THE APPROPRIATE DRIVER IN CONJUNCTION WITH A PROPERLY METERED TORQUE WRENCH, TIGHTEN THE ABUTMENT OR HYBRID RESTORATION TO THE IMPLANT MANUFACTURER'S RECOMMENDED TORQUE VALUE." PER IFU 4849 REV. 4.0 (INCLUSIVE TAPERED IMPLANTS IFU), THE "WARNING" SECTION STATES: "SMALL-DIAMETER IMPLANTS WITH ANGLED ABUTMENTS ARE NOT RECOMMENDED FOR THE POSTERIOR REGION OF THE MOUTH."

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. IF/WHEN THE DEVICE IS RETURNED AN INVESTIGATION WILL BE CARRIED OUT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THERE WAS VERY LITTLE INFORMATION PROVIDED FOR THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERT SNAPPED OFF, PART OF THE INSERT IS STILL WITH THE CROWN. PART OF THE INSERT IS STILL IN THE IMPLANT WHICH THE PROVIDER HAD TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152558 STRAUMAN INCLUSIVE INSERTS STRAUMAN INCLUSIVE INSERTS NDP PRISMATIK DENTALCRAFT, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention