BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD-TITE® SQUARE UNISCREW

    MDR report key: 8742077 · Received June 27, 2019

    Report

    Report Number
    0001038806-2019-00595
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    March 22, 2019
    Report Date
    October 1, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE GOLD-TITE® SQUARE UNISCREW (UNISG) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WEAR ABUT NO DAMAGE TO THE SCREW THREADS. HOWEVER THE COLLAR IS NOTED TO BE FRACTURED LATERALLY AND SHAVED DOWN TO THE BASE HEX FEATURE. NO PREEXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON AN UNKNOWN TOOTH SITE AND USED FOR AN UNKNOWN PERIOD OF TIME PRIOR TO FRACTURE. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE PRODUCT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 220392. 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 (220392) FOR SIMILAR CAUSE 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 PRODUCT (UNISG). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS OCCURRED AND THE REPORTED EVENT WAS CONFIRMED. A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: D4: UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THE DOCTOR INDICATED THAT THE ABUTMENT SCREW FRACTURED THERE WAS NO REPORTED DAMAGE TO THE IMPLANT OR PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534164 GOLD-TITE® SQUARE UNISCREW ABUTMENT SCREW NHA BIOMET 3I 220392

    Patients

    Seq Age Sex Outcome Treatment
    1