BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 3.75 MM 8 MM

    MDR report key: 9295414 · Received November 8, 2019

    Report

    Report Number
    0002023141-2019-01049
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    September 24, 2019
    Report Date
    January 17, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K013494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TWIST MP-1 3.75 MM 8 MM (1988) WAS RETURNED FOR INVESTIGATION ATTACHED WITH THE REPORTED HEALING CAP AND WITH A MATING TRANSFER MOUNT. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WEAR AND DEBRIS ABOUT THE IMPLANT THREADS FROM USAGE. THE TINES ARE NOTED TO BE IN FUNCTIONAL SHAPE. FUNCTIONAL TESTING WAS PERFORMED FOR THE RETURNED PRODUCT AND IT WAS DETERMINED THAT THE HEALING CAP ASSEMBLES AS NORMAL WITH THE IMPLANT. 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. THE ALLEGED DEVICE MALFUNCTION WAS UNCONFIRMED. A ROOT CAUSE CANNOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT D4: DEVICE EXPIRATION D4: UDI D10: DEVICE AVAILABILITY 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 H10: ADDED MANUFACTURER NARRATIVE

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). ADDITIONAL 510K NUMBER: K943604.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALING CAP COULD NOT BE SEATED. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. TOOTH LOCATION 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094060 IMPL TWIST MP-1 3.75 MM 8 MM DENTAL IMPLANT DZE ZIMMER DENTAL 2018090253

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR