BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN GOLD-TITE LARGE HEXED SCREW

    MDR report key: 10683363 · Received October 15, 2020

    Report

    Report Number
    0001038806-2020-01568
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 21, 2020
    Report Date
    December 21, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868006121
    PMA / PMN Number
    K972444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). ONE CERTAIN® GOLD-TITE® LARGE HEXED SCREWS (ILRGHG) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED SCREW IDENTIFIED SIGNS OF USE BUT NO APPARENT MALFUNCTION. FUNCTIONAL TESTING WAS PERFORMED AND THE SCREWS WERE ABLE TO THREAD INTO AND OUT OF APPLICABLE IN-HOUSE IMPLANT. NO PRE-EXISTING CONDITIONS WERE REPORTED. THE DEVICE HAD BEEN PLACED FOR APPROXIMATELY 1 YEAR. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: BIOMET 3I RESTORATIVE PRODUCTS IFU (P-IIS086GR) REV F - OCTOBER 2019. INFORMATION IDENTIFIED: WARNINGS, PRECAUTIONS AND POTENTIAL ADVERSE EVENTS. PER THE APPLICABLE IFU, UNDER SECTION (PRECAUTIONS), IT IS STATED THAT IMPROPER TECHNIQUE COULD CAUSE SCREW LOOSENING. 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 (1223329) 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 (1223329) AND NO SIMILAR EVENT OR COMPLAINT WAS FOUND. POST MARKET TRENDING REVIEW: OCTOBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND FUNCTIONAL TESTING, DEVICE MALFUNCTION DID NOT OCCUR. HOWEVER, THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT WERE NONVERIFIABLE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. EMAIL ADDRESS UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER:K072642.

    Description of Event or Problem · 1

    IT WAS REPORTED CROWN MOBILITY, WHEN CHECK UP DOCTOR NOTICED SCREW LOOSENING. NEW SCREW PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149651 CERTAIN GOLD-TITE LARGE HEXED SCREW DENTAL SCREW DZE BIOMET 3I ILRGHG 1223329 00844868006121

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR