BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN¿ GOLD-TITE¿ HEXED SCREW

    MDR report key: 15769618 · Received November 10, 2022

    Report

    Report Number
    0001038806-2022-01727
    Event Type
    Malfunction
    Date Received
    November 10, 2022
    Date of Event
    October 31, 2022
    Report Date
    March 23, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008538
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    ONE CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM, ILDAT4 AND ONE CERTAIN® GOLD-TITE® HEXED SCREW, UNIHG WAS RETURNED FOR INVESTIGATION. FRACTURE IDENTIFIED AT THE HEAD OF THE SCREW. ABUTMENT HAS DISCOLORATION, DEBRIS AND SIGNIFICANT DAMAGE AT THE CORONAL ASPECT AND THE INTERFACE. SERIAL NUMBER ILLEGIBLE ON THE INTERFACE. FRACTURE OF SCREW AND DAMAGE TO ABUTMENT MAY BE ATTRIBUTED TO ATTEMPTS TO DISENGAGE SCREW AND REMOVAL OF ABUTMENT/SCREW. THE SECOND ILDAT4 AND IUNIHG WERE NOT RETURNED AND THE INVESTIGATION WILL BE OF THE AVAILABLE ITEM AND LOT NUMBER, IFU, DHR AND RISK MANAGEMENT FILES. NO PRE-EXISTING CONDITIONS WERE REPORTED AND A PER WAS NOT PROVIDED. THE DEVICE WAS INTENDED FOR TOOTH POSITION #30 AT THE TIME OF THE REPORTED EVENT. PICTURE/X-RAY: PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. LDA ABUTMENTS ARE SCANNED AND DESIGNED WITHIN THE LAB. ZIMMER BIOMET ONLY MILLS THE DESIGN RECEIVED THROUGH 3SHAPE SOFTWARE. THEREFORE, A COMPARISON BETWEEN THE CUSTOMER DESIGN AND THE PRODUCT SHOULD BE PERFORMED. NO DISCREPANCIES WERE OBSERVED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1221046). 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. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (8448628-4/3). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE'S, 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. A LOT SPECIFIC COMPLAINT HISTORY REVIEW IS NOT CONDUCTED FOR PSP COMPLAINTS. PATIENT SPECIFIC PRODUCTS HAVE A UNIQUE ONE TIME USE LOT NUMBER. THEREFORE, A LOT SPECIFIC HISTORY SEARCH FOR THIS COMPLAINT IS NOT PERFORMED. A LOT SPECIFIC COMPLAINT HISTORY REVIEW FOR SUBJECT NUMBER (1221046) WAS CONDUCTED FOR SIMILAR EVENTS AND REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT. JANUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (LOOSENING/DOES NOT DISENGAGE) OR PRODUCT (ILDAT4 X 2/IUNIHG X 2). BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROSTHETIC SCREW BECAME LOOSE AND DENTIST COULD NOT GET THEM REMOVED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462183 CERTAIN¿ GOLD-TITE¿ HEXED SCREW ABUTMENT SCREW NHA BIOMET 3I IUNIHG 1221046 00844868008538

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female