BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLUSIVE TAPERED IMPLANT 4.2 MMD X 10 MML X 3.5 MMP

    MDR report key: 7082810 · Received December 5, 2017

    Report

    Report Number
    3011649314-2017-00097
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    November 2, 2017
    Report Date
    December 29, 2020
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K121406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION H1: REPORT TYPE CHANGED TO SERIOUS INJURY AS THE PROVIDER NOTES, "PAIN AND MOBILITY." THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DEVICE HISTORY RECORD: THE DHR 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 REVIEW: THE PACKAGED STOCK PRODUCT IS NOT APPLICABLE FOR REVIEW SINCE NO DEFECT OR NON-CONFORMITY OBSERVED FROM RETURNED PRODUCT. RETURNED SAMPLE: THE IMPLANT WAS RETURNED WITH ONE CARRIER AND ONE COVER SCREW BUT NOT IN ORIGINAL PACKAGE. IT WAS VISUALLY INSPECTED AND VERIFIED TO BE AN INCLUSIVE IMPLANT 4.2 MM X 10.0 MM USING THE RADIOGRAPHIC TEMPLATE. COMPLAINT INVESTIGATOR MEASURED THE CRITICAL PARAMETERS AGAINST DRW 3031815 REV 2.0 FROM DHR AND FOUND NO DEVIATION. NO DEFECT OR NON-CONFORMITY WAS OBSERVED. ROOT CAUSE: PROBABLE CAUSES COULD BE THE LOSS OF PRIMARY STABILITY AT THE OSTEOTOMY SITE DUE TO INSUFFICIENT BONE OR POOR BONE QUALITY; EITHER THE BONE WAS TOO SOFT OR THE OPERATOR ERRED IN CREATING AN OSTEOTOMY BIGGER THAN THE SIZE OF THE IMPLANT DIAMETER.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND THE EVALUATION IS ANTICIPATED. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INCLUSIVE TAPERED IMPLANT FAILED TO ACHIEVE THE INITIAL PRIMARY STABILITY. THE IMPLANT WAS SPINNING DURING THE PLACEMENT OF THE IMPLANT. THUS, THE IMPLANT WAS REMOVED ON THE SAME DAY. THE PATIENT IS A SMOKER. THE PATIENT WAS REPORTED TO HAVE PAIN AND MOBILITY IN THE TOOTH ON THE DAY OF THE PROCEDURE. THERE WAS NO INFECTION AT THE IMPLANT SITE. THERE WAS NO ABNORMALITY WITH THE IMPLANT. THERE WAS NO INJURY TO THE PATIENT. THE PATIENT WAS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862541 INCLUSIVE TAPERED IMPLANT 4.2 MMD X 10 MML X 3.5 MMP DENTAL IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0027 6045826

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention