BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 3.75 MM 1 0 MM

    MDR report key: 8254489 · Received January 16, 2019

    Report

    Report Number
    0002023141-2019-00030
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Date of Event
    December 3, 2018
    Report Date
    April 23, 2019
    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

    NO PRODUCT WAS RETURNED FOR INSPECTION. AN X-RAY IMAGE SHOWS THAT THE IMPLANT IS FRACTURED AT THE COLLAR WHILE IN THE SURGICAL SITE. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 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. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. ALSO A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS FOR THIS PRODUCT LOT. A SINGULAR ROOT CAUSE COULD NOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D4: EXPIRATION DATE, UDI: N/A. G4: DATE RECEIVED BY MANUFACTURER. G7: FOLLOW-UP NUMBER. H2: FOLLOW UP TYPE. H4: DEVICE MANUFACTURE DATE. H6: EVALUATION CODES. H10: ADDITIONAL NARRATIVE/DATE.

    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 WEIGHT NOT PROVIDED/UNKNOWN. REPORTER'S EMAIL NOT PROVIDED/UNKNOWN. ADDITIONAL 510K NUMBER: K943604. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT (1989) FRACTURED. THE IMPLANT COULD NOT BE REMOVED DUE TO OSSEO-INTEGRATION. IN THE FUTURE, THE BRIDGE WILL BE PLACED IN THE SITE OF 1ST PREMOLAR/1ST MOLAR. TOOTH LOCATION 29.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46531 IMPL TWIST MP-1 3.75 MM 1 0 MM DENTAL IMPLANT DZE ZIMMER DENTAL 62486035

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR