BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-FIX SELF-DRILLING TENTING SCREW

    MDR report key: 11219125 · Received January 22, 2021

    Report

    Report Number
    1650372-2021-00001
    Event Type
    Malfunction
    Date Received
    January 22, 2021
    Date of Event
    December 23, 2020
    Report Date
    January 22, 2021
    Manufacturer
    OSTEOGENICS BIOMEDICAL, INC.
    Product Code
    DZL
    UDI-DI
    D765PFT41
    PMA / PMN Number
    K093719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE BROKEN SCREW WAS RETURNED BY THE CLINICIAN ALONG WITH 3 UNUSED SCREWS FROM THE SAME LOT. THE MINOR PITCH OF THE THREAD ON THE SCREWS WAS MEASURED AND WAS WITHIN TOLERANCE OF THE SPECIFICATION. ADDITIONALLY, THE THREE UNUSED SCREWS THAT WERE RETURNED WERE SUBJECTED TO A SCREW-IN TEST INTO AN APPROPRIATE CHALLENGE MEDIUM AND DID NOT BREAK. THIS IS THE FIRST COMPLAINT OF THIS TYPE.

    Description of Event or Problem · 1

    A TITANIUM TENTING SCREW SHEARED OFF ALONG THE SHANK OF THE SCREW WHILE BEING INSERTED INTO THE CORTICAL BONE OF THE POSTERIOR MANDIBLE. THE PORTION OF THE SCREW THAT WAS LEFT IN THE BONE WAS THEN RETRIEVED BY MEANS OF CREATING AN OSTEOTOMY THAT WAS SLIGHTLY LARGER THAN THE 1.5 MM DIAMETER OF THE SHANK. THE CLINICIAN BELIEVES THAT THIS OSTEOTOMY WILL HEAL IN A SIMILAR WAY TO THE OTHER CORTICAL PERFORATIONS THAT WERE BEING CREATED AS PART OF THE SURGICAL PROTOCOL BEING EMPLOYED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113872 PRO-FIX SELF-DRILLING TENTING SCREW DENTAL SELF-DRILLING TENTING SCREW DZL OSTEOGENICS BIOMEDICAL, INC. PFT4 Y04018 D765PFT41

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention