BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAIN TITANIUM LARGE HEXED SCREW

    MDR report key: 11085992 · Received December 29, 2020

    Report

    Report Number
    0001038806-2020-02136
    Event Type
    Injury
    Date Received
    December 29, 2020
    Date of Event
    July 7, 2020
    Report Date
    April 13, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K972444
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4) THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM G3: DATE RECEIVED BY MANUFACTURER H1: TYPE OF REPORT, FOLLOW-UP NUMBER H2: FOLLOW UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES' H6: EVALUATION CODES H10: ADDITIONAL NARRATIVE ONE FULL OSSEOTITE® TAPERED IMPLANT 4 X 10MM (FNT410) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF DAMAGE ABOUT THE EXTERNAL THREADS. THE INTERNAL DRIVE FEATURE IS NOTED TO CONTAIN A FRACTURED SCREW PIECE IN THE DRIVE FEATURE,WHICH IS NOTED TO BE THE ILRGHT SCREW. THIS PIECE COULD NOT BE DISENGAGED FROM THE DRIVE FEATURE. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER.THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 16 (FDI) AND USED FOR APPROXIMATELY 4 YEARS.THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT (FRACTURE). REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: ZBINSTSM REV. B 12/19; TORQUE MATRIX - INTERNAL CONNECTION; PAGE 8-9 DHR REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT WITHIN SPECIFICATIONS. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE ILRGHT DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW 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 (SCREW FRACTURE) OR PRODUCT (ILRGHT ). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS OCCURRED. THE RETURNED IMPLANT COULD NOT DISENGAGE FROM THE FRACTURED SCREW PIECE. THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. LOT AND UDI NUMBER UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER: K072642.

    Description of Event or Problem · 1

    DOCTOR REPORTED THE SCREW FRACTURED INSIDE THE IMPLANT. THE DOCTOR WAS NOT ABLE TO REMOVE THE FRACTURED PORTION AND IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553568 CERTAIN TITANIUM LARGE HEXED SCREW DENTAL SCREW DZE BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention