BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® TITANIUM LARGE HEXED SCREW

    MDR report key: 9713696 · Received February 14, 2020

    Report

    Report Number
    0001038806-2020-00361
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    September 26, 2018
    Report Date
    April 27, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K972444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, A DEVICE HISTORY REVIEW AND COMPLAINT HISTORY REVIEW COULD NOT BE COMPLETED. WITHOUT THE RETURNED PRODUCT, THERE IS NOT ENOUGH EVIDENCE TO FORM A CONCLUSION ON THE REPORTED EVENT. THEREFORE, THE COMPLAINT IS NON-VERIFIABLE. A ROOT CAUSE CANNOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: H3: CHANGED "NO" TO "YES."

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). PATIENT WEIGHT NOT PROVIDED/UNKNOWN. DEVICE LOT NUMBER NOT PROVIDED/UNKNOWN. ADDITIONAL 510K NUMBER: K072642. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABUTMENT SCREW FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176958 CERTAIN® TITANIUM LARGE HEXED SCREW ABUTMENT SCREW DZE BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR