BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® TITANIUM LARGE HEXED SCREW

    MDR report key: 13597511 · Received February 25, 2022

    Report

    Report Number
    0001038806-2022-00282
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    December 1, 2021
    Report Date
    August 10, 2022
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868006138
    PMA / PMN Number
    K972444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). PMA/510(K) NUMBER: K072642.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A SCREW WAS RETURNED FOR INVESTIGATION,VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WORN MARKINGS DUE TO USAGE AND A FRACTURE AT THE THREADS. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. PRE-EXISTING CONDITIONS WERE NOTED ON THE COMPLAINT WERE BRUXISM. THE REPORTED DEVICE LOCATION AND USAGE IS UNKNOWN. PICTURES OR X-RAY 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' 'POTENTIAL ADVERSE EVENTS. DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1226423). 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: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1226423) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: FRACTURE : SCREW. POST MARKET TREND REVIEW: JUNE POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREW FROM CROWN FRACTURED AT THE TIP OF THE SCREW. PROCEDURE WAS COMPLETED WITH ANOTHER SCREW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREW FROM CROWN FRACTURED AT THE TIP OF THE SCREW. PROCEDURE WAS COMPLETED WITH ANOTHER 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
    1231664 CERTAIN® TITANIUM LARGE HEXED SCREW DENTAL SCREW DZE BIOMET 3I ILRGHT 1226423 00844868006138

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male