BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE TAPERED IMPLANT 4.7 MMD X 11.5 MML X 4.5 MMP

    MDR report key: 14863101 · Received June 29, 2022

    Report

    Report Number
    3011649314-2022-00377
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    April 21, 2022
    Report Date
    November 19, 2024
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K121406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. PATIENT'S WEIGHT WAS NOT RECORDED AT THE TIME OF VISIT. PATIENT'S RACE WAS NOT RECORDED AT THE TIME OF VISIT.

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS. THE DHR WAS REVIEWED FOR LOT# 6081288 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. THE PACKAGED STOCK PRODUCT IS NOT APPLICABLE FOR REVIEW SINCE NO DEFECT WAS OBSERVED FROM THE RETURNED PRODUCT. INVESTIGATION METHODS/RESULTS. THE DEVICE WAS RETURNED BUT NOT IN ORIGINAL PACKAGE. THE IMPLANT WAS VERIFIED TO BE AN INCLUSIVE TAPERED IMPLANT 4.7 MMD X 11.5 MML X 4.5 MMP (70-1070-IMP0012) USING RADIOGRAPHIC TEMPLATE (DOC #3006704_4.0). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. SIGNIFICANT BONE DEBRIS WAS OBSERVED IN THE THREADING OF THE IMPLANT. ROOT CAUSE. A ROOT CAUSE FOR THIS COMPLAINT CANNOT BE EXPLICITLY DETERMINED. PROBABLE ROOT CAUSE IS IMPROPER SEATING OF THE IMPLANT DRIVER INTO THE INTERNAL HEX OF THE IMPLANT. ADDITIONALLY, IT IS UNCLEAR THE METHODS OF IMPLANT PLACEMENT USED DURING THE INITIAL PROCEDURE OR IF APPROPRIATE LOAD DISTRIBUTION WAS OBSERVED. PER IFU- 570 REV 3.0 (HAHN TAPERED IMPLANT SYSTEM IFU), THE "IMPLANT PLACEMENT" SECTION STATES: "USE SLIGHT FINGER PRESSURE TO PINCH THE OCCLUSAL END OF THE IMPLANT IN ITS HOLDER WHILE INSERTING THE APPROPRIATE IMPLANT DRIVER. GENTLY ROTATE IMPLANT AND HOLDER, ALLOWING THE DRIVER TO ENGAGE THE IMPLANT CONNECTION. WITH THE DRIVER SECURELY ATTACHED TO THE IMPLANT, SQUEEZE THE OPPOSING END OF THE HOLDER TO DISENGAGE THE IMPLANT FROM THE HOLDER. TRANSPORT THE IMPLANT TO THE PREPARED SITE, AND INSERT INTO THE OSTEOTOMY. ROTATE CLOCKWISE WITH APPLIED PRESSURE TO ENGAGE THE SELF-TAPPING GROOVES. AVOID LATERAL FORCES, WHICH CAN AFFECT THE ANGULATION AND FINAL ALIGNMENT OF THE IMPLANT. ADVANCEMENT AND FINAL SEATING - CONTINUE THREADING THE IMPLANT INTO THE OSTEOTOMY SITE USING THE PREFERRED PLACEMENT METHOD. A MINIMUM TORQUE VALUE OF 35 NCM UPON FINAL SEATING INDICATES GOOD PRIMARY STABILITY.

    Additional Manufacturer Narrative · 0

    NOTE: G3 IN THE INITIAL REPORT WAS REPORTED AS (06-02-2022), HOWEVER, THE CORRECT DATE IS (04-21-2022). CAPA CA-00016 MANUFACTURER REFERENCE: COMP-(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INCLUSIVE TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS UNKNOWN. THE PATIENT PRESENTED ON (B)(6) 2022 FOR A PRIMARY PROCEDURE ON TOOTH #30. DURING THE INITIAL PLACEMENT, THE PROVIDER NOTES THAT HE WAS UNABLE TO EASILY PUT THE IMPLANT IN PLACE, SOMETHING WAS STOPPING ME NOR WOULD THE SCREW GO ON TOP. IT IS FOR THIS REASON THE IMPLANT WAS NOT SEATED. I WOULD ALSO NOTE THAT THE PROVIDER IS RETURNING THE IMPLANT AND THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135778 INCLUSIVE TAPERED IMPLANT 4.7 MMD X 11.5 MML X 4.5 MMP INCLUSIVE TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0012 6099154

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Female