BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® TITANIUM LARGE HEXED SCREW

    MDR report key: 8342590 · Received February 15, 2019

    Report

    Report Number
    0001038806-2019-00116
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Date of Event
    November 16, 2018
    Report Date
    May 23, 2019
    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

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE CERTAIN® TITANIUM LARGE HEXED SCREW (ILRGHT) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED PRODUCT IDENTIFIED FRACTURE ON THE SCREW NECK WITH THE THREADED PORTION OF THE SCREW BROKEN OFF. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCES WERE NOTED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1212216) FOR SIMILAR EVENTS AND 2 OTHER RELEVANT COMPLAINTS WERE IDENTIFIED. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: DOCUMENTS REVIEWED: BIOMET 3I RESTORATIVE IFU (P-IIS086GR REV. E 11/2015) & BIOMET 3I RESTORATIVE MANUAL (INSTRM REV B 10/15) INFORMATION IDENTIFIED: WARNINGS PRECAUTIONS POTENTIAL ADVERSE EFFECTS DOCUMENTS REVIEWED: SURGICAL MANUAL: TAPERED & PARALLEL WALLED IMPLANTS INSTSM REV 02/16 INFORMATION IDENTIFIED: TORQUE MATRIX - INTERNAL CONNECTION. COMPLAINT REPORTED THAT THE SCREWS FRACTURED. THE REPORTED EVENT IS CONFIRMED AS VISUAL INSPECTION IDENTIFIED FRACTURE ON THE RETURNED SCREW. A ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: DATE OF THIS REPORT. EXPIRATION DATE, UDI: (B)(4). DATE RECEIVED BY MANUFACTURER. TYPE OF REPORT, FOLLOW-UP NUMBER. FOLLOW UP TYPE. DEVICE EVALUATED BY MANUFACTURER: CHANGE 'NO' TO 'YES'. DEVICE MANUFACTURE DATE. EVALUATION CODES.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL PMA/510(K) NUMBER K072642.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ILRGHT SCREW WAS FRACTURED. DOCTOR WAS ABLE TO REMOVE THE FRACTURED PORTION FROM THE IMPLANT. IMPLANT IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138149 CERTAIN® TITANIUM LARGE HEXED SCREW ABUTMENT SCREW DZE BIOMET 3I 1212216

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR