BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAIN® TITANIUM LARGE HEXED SCREW

    MDR report key: 9716449 · Received February 17, 2020

    Report

    Report Number
    0001038806-2020-00369
    Event Type
    Injury
    Date Received
    February 17, 2020
    Date of Event
    July 12, 2019
    Report Date
    April 23, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K972444
    Adverse Event
    Yes
    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: B4: DATE OF THIS REPORT. G4: DATE RECEIVED BY MANUFACTURER. G7: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: CHANGED "NO" TO "YES". H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL PMA/510(K) NUMBERS: K072642. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW FRACTURED INSIDE THE IMPLANT. THE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181032 CERTAIN® TITANIUM LARGE HEXED SCREW SCREW DZE BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention