BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSSEOTITE® IMPLANT 4 X 13MM

    MDR report key: 8495803 · Received April 9, 2019

    Report

    Report Number
    0001038806-2019-00299
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Date of Event
    March 8, 2019
    Report Date
    July 1, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K063286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE OSSEOTITE® IMPLANT 4 X 13MM (OSS413) WAS NOT RETURNED. SINCE PRODUCT HAS NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE IMPLANT REMAINS IMPLANTED. THE RETURNED X-RAY SHOWED THAT THE IMPLANT IS FRACTURED AT THE THREADED REGION WITH WITHIN THE SURGICAL SITE. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 241504. 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 241504 FOR SIMILAR CAUSE AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY CAUSE RELATED TO THE EVENT IS PATIENT PARAFUNCTION OVER THE COURSE OF 15 YEARS. HOWEVER, IT CAN BE ASSOCIATED TO INADEQUATE TREATMENT PLANNING. 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). DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED A FRACTURE OF AN IMPLANT (OSS413) DURING A CHECK UP. UPPER PART OF THE IMPLANT WAS DISCARDED AND LOWER PART REMAINS IMPLANTED. TOOTH LOCATION 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290315 OSSEOTITE® IMPLANT 4 X 13MM DENTAL IMPLANT DZE BIOMET 3I 241504

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR