BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TWIST MTX 3.75 MM 15 MM

    MDR report key: 8894787 · Received August 14, 2019

    Report

    Report Number
    0002023141-2019-00555
    Event Type
    Injury
    Date Received
    August 14, 2019
    Date of Event
    June 19, 2019
    Report Date
    October 25, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K013494
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SPLINE TWIST IMPLANT WITH MTX SURFACE (1982) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF WEAR DUE TO USAGE. ADDITIONALLY, THERE WAS BONE RESIDUE AROUND THE EXTERNAL THREADS.MEASUREMENTS WERE TAKEN USING A CALIPER. THROUGH DIMENSIONAL ANALYSIS AND COMPARISON TO DRAWING, IT WAS DETERMINED THAT THE PRODUCT MET DESIGN SPECIFICATION. NO DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. APPROPRIATE DOCUMENTATION WAS REVIEWED. PROBABLE CAUSES 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, D3: MANUFACTURER, G2: MANUFACTURER'S CONTACT OFFICE, G4: DATE RECEIVED BY MANUFACTURER, G7: CHECKED "FOLLOW-UP", H2: CHECKED FOLLOW-UP TYPE, H3: CHANGED "NO" TO "YES", 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). PATIENT'S AGE: UNKNOWN. DEVICE LOT NUMBER: UNKNOWN. REPORTER'S EMAIL: UNKNOWN. ADDITIONAL 510K NUMBER: K943604.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED BONE LOSS. AS A RESULT, THE IMPLANT (1982) HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686415 IMPL TWIST MTX 3.75 MM 15 MM DENTAL IMPLANT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention