BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 5.0 MM 8 MM

    MDR report key: 10468630 · Received August 28, 2020

    Report

    Report Number
    0002023141-2020-01317
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Date of Event
    July 18, 2020
    Report Date
    December 9, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K013494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: METHOD CODE WAS ADDED: 3331, 4109 AND 10. H6: RESULTS CODE WAS ADDED: 213. H6: CONCLUSIONS CODE WAS ADDED: 4310. H10: NARRATIVE/DATA WAS UPDATED. THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. THE REPORTED CONDITION OF THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT WAS NOT CONFIRMED. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED MINOR SIGNS OF WEAR AROUND THE EXTERNAL THREADS DUE TO USAGE. THE DEVICE HAD NO APPARENT MALFUNCTION. FUNCTIONAL TESTING WAS CONDUCTED. THE RETURNED DEVICES WERE ABLE TO ENGAGE AND DISENGAGE AS NORMAL. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE REPORTED DEVICE LOT. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THE REPORTED DEVICE LOT FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. FINDING A ROOT CAUSE IS NOT APPLICABLE TO THIS INVESTIGATION AS THE REPORTED MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS UNCONFIRMED. 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 ADDITIONAL OR CORRECTED 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 IS NOT PROVIDED/UNKNOWN. ADDITIONAL 510(K) NUMBER IS K962106.

    Description of Event or Problem · 1

    DOCTOR REPORTS THAT THE 1993 IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. ANOTHER IMPLANT WAS PLACED. TOOTH SITE # 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930916 IMPL TWIST MP-1 5.0 MM 8 MM DENTAL IMPLANT DZE ZIMMER DENTAL 2018041516

    Patients

    Seq Age Sex Outcome Treatment
    1