BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLANT IMPLANT

    MDR report key: 11862611 · Received May 21, 2021

    Report

    Report Number
    3001617766-2021-02928
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Report Date
    August 27, 2021
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307103981
    PMA / PMN Number
    K061319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED B4 FOR REPORT SUBMISSION DATE, G1 FOR CONTACT INFORMATION, G3 FOR AWARENESS DATE OF NEW INFORMATION, G6 FOR REPORT TYPE AND SECTIONS D9, H1, H2, H3, AND H6 TO REPORT THAT THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    PATIENT'S IDENTIFIER, AGE, SEX, WEIGHT, DATE OF EVENT, OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS WERE NOT PROVIDED. WHEN THE REQUESTED INFORMATION BECOMES AVAILABLE, A SUPPLEMENTARY REPORT WILL BE SUBMITTED. EXPLANTED DATE IS UNKNOWN DEVICE EVALUATION RESULTS ARE NOT AVAILABLE. WHEN THE ANALYSIS IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PER COMPLAINT (B)(4) DURING CLINICAL PROCEDURE, PRODUCT COULD NOT BE SEPERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760361 REPLANT IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC NA 160066 10841307103981

    Patients

    Seq Age Sex Outcome Treatment
    1