BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM HEXED UNISCREW

    MDR report key: 8497486 · Received April 9, 2019

    Report

    Report Number
    0001038806-2019-00303
    Event Type
    Injury
    Date Received
    April 9, 2019
    Date of Event
    February 27, 2019
    Report Date
    July 11, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FRACTURED PIECE OF THE TITANIUM HEXED UNISCREW (UNIHT) WAS RETURNED FOR INVESTIGATION INSIDE OSSEOTITE® IMPLANT 4 X 13MM (OSS413). VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED THAT THE IMPLANT IS BADLY DAMAGED FROM REMOVAL, AND THE EXTERNAL HEX IS WORN DOWN. THE INTERNAL DRIVE FEATURE IS CONFIRMED TO CONTAIN THE REPORTED SCREW (UNIHT), WHICH WAS TOO BADLY DAMAGED TO BE REMOVED. DEVICE WAS USED FOR APPROXIMATELY 12 YEARS. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1222207). 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 WAS PERFORMED FOR THE REPORTED LOT NUMBER (1222207) FOR SIMILAR CAUSE AND NO OTHER COMPLAINT WAS IDENTIFIED. APRIL POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT(SCREW FRACTURE) OR DEVICES (UNIHT). THEREFORE, BASED ON THE EVALUATION, DEVICE MALFUNCTION (SCREW FRACTURE) DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED. A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: D4: UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW (UNIHT) FRACTURED INSIDE THE IMPLANT. IMPLANT WAS REMOVED. TOOTH LOCATION 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289763 TITANIUM HEXED UNISCREW SCREW NHA BIOMET 3I 1222207

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention OSS413