BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® TITANIUM LARGE HEXED SCREW

    MDR report key: 7367361 · Received March 23, 2018

    Report

    Report Number
    0001038806-2018-00306
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    March 12, 2018
    Report Date
    July 18, 2018
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    PK972444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE EVALUATION OF THE DEVICE PERFORMED ON MAY 16, 2018, IT WAS DETERMINED THAT THE ABUTMENT SCREW WAS NOT FRACTURED AS REPORTED BY THE CUSTOMER. THE EVENT REPORTED IN MFR 0001038806-2018-00306 SUBMITTED ON MAR 23, 2018, NO LONGER MEETS REPORTABILITY REQUIREMENTS. NO ADDITIONAL MEDWATCH REPORTS WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT PROVIDED/UNKNOWN. (B)(4). DEVICE LOT NUMBER NOT PROVIDED/UNKNOWN. ADDITIONAL 510K NUMBER: K072642.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABUTMENT SCREW (ILRGHT) FRACTURED. THE FRACTURED PIECE WAS REMOVED FROM THE IMPLANT AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210409 CERTAIN® TITANIUM LARGE HEXED SCREW ABUTMENT SCREW DZE BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1