BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® HEXED SCREW

    MDR report key: 13800624 · Received March 17, 2022

    Report

    Report Number
    0001038806-2022-00374
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Date of Event
    January 31, 2022
    Report Date
    July 7, 2022
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008538
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES'. ONE CERTAIN® GOLD-TITE® HEXED SCREW (IUNIHG) WAS RETURNED FOR INVESTIGATION (SEE IMAGES ATTACHED IN THE COMPLAINT). VISUAL EVALUATION OF THE AS RETURNED SCREW IDENTIFIED SIGNS OF USE BUT NO APPARENT SIGNS OF MALFUNCTION. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED. THE DEVICE WAS INTENDED FOR TOOTH #11. X-RAY & PICTURE EVALUATION: X-RAY / PICTURE WAS NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENT REVIEWED: BIOMET 3I RESTORATIVE PRODUCTS IFU (P-IIS086GR) REV F - OCTOBER 2019. INFORMATION IDENTIFIED: CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND POTENTIAL ADVERSE EVENTS. PER THE APPLICABLE IFU, IT IS STATED THAT OVERLOADING AND IMPROPER TECHNIQUE MAY LEAD TO DEVICE FAILURE SUCH AS SCREW LOOSENING. DHR REVIEW: DHR REVIEW FOR THE LOT (1223162) 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 ZIMVIE. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1223162) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: LOOSENING) AND TWO OTHER COMPLAINTS WERE IDENTIFIED. POST MARKET TRENDING REVIEW: APRIL 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 DEVICE MALFUNCTION DID NOT OCCUR. ADDITIONALLY, THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT WERE NONVERIFIABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED LOOSENING OF THE PROSTHETIC SCREW. REMOVAL AND REPLACEMENT OF THE SCREW.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38048 CERTAIN® GOLD-TITE® HEXED SCREW DENTAL SCREW NHA BIOMET 3I IUNIHG 1223162 00844868008538

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female