BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® TITANIUM LARGE HEXED SCREW

    MDR report key: 8773320 · Received July 9, 2019

    Report

    Report Number
    0001038806-2019-00655
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    April 26, 2019
    Report Date
    October 24, 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

    TWO CERTAIN® TITANIUM LARGE HEXED SCREW (ILRGHT) WERE RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCTS IDENTIFIED FRACTURES ON THE NECKS OF BOTH SCREWS. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICES & EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER, THE PATIENT HAD UNKNOWN BONE DENSITY. THE REPORTED DEVICES WERE LOCATED ON TOOTH # 44 & 46 AND WERE USED FOR AN UNKNOWN DURATION. THE CUSTOMER DID NOT PROVIDE PICTURES OR X-RAY IMAGES. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1220468). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1220468) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. JULY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (SCREW FRACTURE) OR DEVICE (ILRGHT). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED FOR BOTH DEVICES. A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED.THIS REPORT IS RELATED TO 0001038806-2019-00656-1.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT TWO ABUTMENT SCREWS FRACTURED ON IMPLANTS AT TOOTH SITES 44 AND 46. THE SCREW FRAGMENTS WERE REMOVED AND THE IMPLANTS REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564577 CERTAIN® TITANIUM LARGE HEXED SCREW ABUTMENT SCREW DZE BIOMET 3I 1220468

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR