BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SURGICAL TRAY

    MDR report key: 14403630 · Received May 14, 2022

    Report

    Report Number
    3001617766-2022-02425
    Event Type
    Injury
    Date Received
    May 14, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 25, 2022
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    KCT
    UDI-DI
    10841307117537
    PMA / PMN Number
    K142519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANT AND EXPLANT DATES WERE NOT PROVIDED. IF THE REQUESTED INFORMATION BECOMES AVAILABLE, A SUPPLEMENTARY REPORT WILL BE SUBMITTED. PATIENT WEIGHT IS UNKNOWN DEVICE EVALUATION RESULTS ARE NOT AVAILABLE. IF THE ANALYSIS IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    FOLLOW-UP SUBMITTED TO REPORT DEVICE EVALUATION.

    Description of Event or Problem · 0

    PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, THERE WAS A BROKEN/FRACTURED COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039269 COMPLETE SURGICAL TRAY DENTAL IMPLANT KCT IMPLANT DIRECT SYBRON MANUFACTURING LLC NA 87072 10841307117537

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention