BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SP 3.7MM 10M M OCTAGON

    MDR report key: 9363457 · Received November 22, 2019

    Report

    Report Number
    0002023141-2019-01161
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Report Date
    January 28, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K082639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TAPERED SWISSPLUS IMPLANT WITH MTX SURFACE (SPB10) AND FIXTURE MOUNT WERE RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED MINOR SIGNS OF WEAR DUE TO USAGE. FUNCTIONAL TESTING WAS PERFORMED TO DISENGAGE THE FIXTURE MOUNT UNSUCCESSFULLY. THE DEVICES COULDN¿T BE SEPARATED AND WERE DETERMINED TO BE STUCK TOGETHER. NO FURTHER TESTING COULD BE PERFORMED AS THE PRODUCTS WOULD NOT DISENGAGE. 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 CONFIRMED. A ROOT CAUSE CANNOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT D4: DEVICE EXPIRATION D4: UDI 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). PATIENT INFORMATION NOT PROVIDED/UNKNOWN. EVENT DATE NOT PROVIDED/UNKNOWN. REPORTER'S NAME AND EMAIL NOT PROVIDED/UNKNOWN. ADDITIONAL 510K NUMBERS: K011245 AND K002188.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PLACEMENT, THE MOUNT WOULD NOT DISENGAGE FROM THE IMPLANT. THE MOUNT AND IMPLANT ARE A BUNDLED ITEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155306 IMPL TAPERED SP 3.7MM 10M M OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL 63893467

    Patients

    Seq Age Sex Outcome Treatment
    1