BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 10MM

    MDR report key: 8892318 · Received August 14, 2019

    Report

    Report Number
    0001038806-2019-00861
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Report Date
    October 25, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K130949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT PACKAGING WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS AGAINST THIS LOT. APPROPRIATE DOCUMENTATION WAS REVIEWED. A ROOT CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED AS THE EVENT CANNOT BE RECREATED. COMPLAINT IS THEREFORE NON-VERIFIABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT D4: DEVICE EXPIRATION D4: (01)00844868021957(17)240225(10)2019020923(241)XIFNT410 G4: DATE RECEIVED BY MANUFACTURER G7: CHECKED "FOLLOW-UP" H2: CHECKED FOLLOW-UP TYPE H3: CHANGED "NO" TO "YES" H4: DATE OF MANUFACTURE H6: ENTERED EVALUATION CODES.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION NOT PROVIDED/UNKNOWN. EVENT DATE NOT PROVIDED/UNKNOWN. REPORTER'S LAST NAME NOT PROVIDED/UNKNOWN. DEVICE NOR THE PACKAGING WAS RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT (XIFNT410) WAS MISSING FROM THE BLISTER PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688931 OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 10MM DENTAL IMPLANT DZE BIOMET 3I 2019020923

    Patients

    Seq Age Sex Outcome Treatment
    1