BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 5.0 MM 8 MM

    MDR report key: 9100699 · Received September 20, 2019

    Report

    Report Number
    0002023141-2019-00768
    Event Type
    Malfunction
    Date Received
    September 20, 2019
    Date of Event
    August 8, 2019
    Report Date
    November 27, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K013494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE IMPLANT WAS RETURNED BUT THE GINGIVAL CUFF WAS NOT RETURNED. THEREFORE, THE REPORTED EVENT COULD NOT BE VERIFIED. FUNCTIONAL TESTING REVEALED THAT THE IMPLANT HAD STRIPPED DRIVE FEATURE AND DAMAGED PLATFORM, LIKELY FROM USAGE. BASED ON THE EVALUATION AND FUNCTIONAL TESTING, THE IMPLANT HAD MALFUNCTIONED. DHR REVIEW FOR THE LOT HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCE WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. DHR REVIEW COULD NOT BE PERFORMED FOR THE GINGIVAL CUFF SINCE THE LOT NUMBER WAS UNKNOWN. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE LOT FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO NEW INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT AGE IS NOT PROVIDED / UNKNOWN, PATIENT WEIGHT IS NOT PROVIDED / UNKNOWN. INITIAL REPORTER¿S TITLE AND EMAIL ADDRESS ARE NOT PROVIDED / UNKNOWN. ADDITIONAL 510(K) NUMBER IS K962106. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT THE HEALING ABUTMENT DID NOT FIT IN THE IMPLANT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. THE HEALING ABUTMENT WAS USED IN THE NEW IMPLANT. PAIN AND INFLAMMATION WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893264 IMPL TWIST MP-1 5.0 MM 8 MM DENTAL IMPLANT DZE ZIMMER DENTAL 2018091239

    Patients

    Seq Age Sex Outcome Treatment
    1