BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN GOLD-TITE HEXED SCREW

    MDR report key: 11392741 · Received March 1, 2021

    Report

    Report Number
    0001038806-2021-00357
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Report Date
    July 15, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868031413
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CERTAIN® GOLD-TITE® HEXED SCREW (IUNIHG) AND ASSOCIATED ABUTMENT/CROWN WERE RETURNED FOR INVESTIGATION. THE COMPLAINT ALLEGED THAT THE ABUTMENT KEPT COMING LOOSE IN THE PATIENT¿S MOUTH. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED SIGNS OF WEAR AROUND THE SCREW HEX BUT NO APPARENT SIGNS OF MALFUNCTION. ADDITIONALLY, THE SCREW DEVICES AND CROWN WERE STILL ENGAGED. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE DEVICES AND CROWN WERE STILL ENGAGED. THEREFORE, DEVICE MALFUNCTION COULD NOT BE VERIFIED/CONFIRMED. NO PRE-EXISTING CONDITIONS WERE NOTED. THE DEVICES HAD BEEN PLACED ON TOOTH #13 FOR AN UNKNOWN PERIOD OF TIME. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. ALSO, ACCORDING TO THE IFU, PATIENT FACTORS LIKE PRESENCE OF OCCLUSAL ABNORMALITIES OR PARAFUNCTIONAL HABITS (E.G. SEVERE BRUXISM, CLENCHING, OVERLOADING, OR GNAWING) MAY CAUSE SCREW LOOSENING, RESTORATION FRACTURE, AND/OR IMPLANT FAILURE. DHR REVIEW FOR THE LOT (1223789) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1223789) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: LOOSENING) AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED. ADDITIONALLY, THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT WERE NONVERIFIABLE.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D1: BRAND NAME. D2: TYPE OF THE DEVICE. D4: CATALOG NUMBER. D4: LOT/SERIAL # . D4: DEVICE EXPIRATION DATE. D4: DEVICE UDI NUMBER. D9: DEVICE AVAILABILITY . G3: DATE RECEIVED BY MANUFACTURER. G4: PMA/510(K) NUMBER. G6: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H4: DEVICE MANUFACTURER DATE. H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. GENDER UNKNOWN / NOT PROVIDED. PATIENT WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABUTMENT KEPT COMING LOOSE IN PATIENTS MOUTH, WOULD NOT STAY ENGAGE WITH IMPLANT (ILL-FITTING). NOT PART OF THE RECALL. TOOTH #13.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288569 CERTAIN GOLD-TITE HEXED SCREW DENTAL SCREW NHA BIOMET 3I ILDAT5 1223789 00844868031413

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention