BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEP DRILL EXTRA LONG (6-28MML)

    MDR report key: 12582106 · Received October 6, 2021

    Report

    Report Number
    3001617766-2021-05872
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    September 28, 2021
    Report Date
    November 23, 2021
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZI
    UDI-DI
    10841307117216
    PMA / PMN Number
    K081396
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP SUBMITTED TO REPORT DEVICE EVALUATION. UPDATED SECTION B4 FOR REPORT SUBMISSION DATE AND B6 TO REPORT DEVICE EVALUATION RESULTS. UPDATED D9 FOR DEVICE RETURN DATE, G1 FOR FOLLOW-UP REPORT SUBMITTER, G3 FOR AWARENESS DATE AND G6 FOR REPORT TYPE AND FOLLOW-UP NUMBER. UPDATED H2 FOR FOLLOW-UP TYPE, H3 FOR DEVICE EVALUATION STATUS AND H6 METHOD, RESULT AND CONCLUSION CODES.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER WAS NOT PROVIDED. IF THE REQUESTED INFORMATION BECOMES AVAILABLE, A SUPPLEMENTARY REPORT WILL BE SUBMITTED. PATIENT AGE AND WEIGHT ARE UNKNOWN. IMPLANT DATE AND EXPLANT DATE ARE NOT APPLICABLE SINCE THE PRODUCT WAS NEVER PLACED AND NOT REMOVED. DEVICE EVALUATION RESULTS ARE NOT AVAILABLE. IF THE ANALYSIS IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PER (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479871 STEP DRILL EXTRA LONG (6-28MML) DENTAL IMPLANT DZI IMPLANT DIRECT SYBRON MANUFACTURING LLC NA 142273 10841307117216

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention