BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP TM 4.1MM MTX FULL,10M

    MDR report key: 8010310 · Received October 26, 2018

    Report

    Report Number
    0002023141-2018-00871
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Date of Event
    September 18, 2018
    Report Date
    March 5, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K132258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A FULL MTX TRABECULAR METAL IMPLANT (TMT4B10) WAS RECEIVED WITH A FIXTURE MOUNT ENGAGED INTO THE DRIVE FEATURE AND A UNIVERSAL FIXTURE MOUNT SCREW. VISUAL INSPECTION OF THE RETURNED PRODUCTS IDENTIFIED GOUGES AROUND THE TOP THREADS AND THE MICRO GROOVES OF THE IMPLANT, THERE WERE NOTICEABLE SIGNS OF USAGE AROUND TM SHELL AND THE MOUNT. THE MALFUNCTION HAS OCCURRED AND THE REPORTED EVENT WAS CONFIRMED. REVIEW OF THE DHR FOR TMT4B10 DID NOT PROVIDE ANY INDICATION OF A MANUFACTURING NONCONFORMITIES/DEVIATION OR MATERIAL DEFICIENCIES THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. LOT WAS INSPECTED AND ACCEPTED 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. D3: MANUFACTURER. D4: EXPIRATION DATE, UDI: (B)(4). D10: DEVICE AVAILABILITY. G1-G2: CONTACT OFFICE - NAME/ADDRESS. G4: DATE RECEIVED BY MANUFACTURER. G7: FOLLOW-UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE "NO" TO "YES". 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

    (B)(4). ADDITIONAL 510K NUMBERS: K113753 AND K112160. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOUNT WOULD NOT DISENGAGE FROM THE IMPLANT (TMT4B10). ANOTHER IMPLANT WAS PLACED. TOOTH LOCATION 28.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850970 IMP TM 4.1MM MTX FULL,10M DENTAL IMPLANT DZE ZIMMER DENTAL 63338746

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR