BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 5.0 MM 10 MM

    MDR report key: 8001836 · Received October 24, 2018

    Report

    Report Number
    0002023141-2018-00860
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Date of Event
    September 25, 2018
    Report Date
    March 5, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K013494
    Removal / Correction Number
    N/A
    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 AND CORRECTED INFORMATION AS A SUPPLEMENT TO (B)(4). THE FOLLOWING SECTIONS ARE BEING REPORTED: B5: NO NEW OR ADDITIONAL INFORMATION D4: 31 AUG 2021 D6: (B)(6) 2018. D7: (B)(6) 2018. D10: 02 NOV 2018. G4:20 FEB 2019. G7: FOLLOW UP. H1: MALFUNCTION. H3: YES. H4:24 AUG 2016. H8: CORRECTION: INITIAL USE OF THE DEVICE. THE REPORTED COMPLAINT DEVICE WAS RECEIVED FOR EVALUATION WITH THE FIXTURE MOUNT ENGAGED INTO THE DRIVE FEATURE. VISUAL INSPECTION AND FUNCTIONAL TESTING CONFIRMED THAT THE MOUNT COULD NOT BE DISENGAGED FROM THE IMPLANT DRIVE FEATURE AS THE HEX DRIVER WAS UNABLE TO UNSCREW THE MOUNT SCREW. THE REPORTED CONDITION OF A MOUNT THAT WOULD NOT DISENGAGE FROM THE IMPLANT WAS CONFIRMED. A DEVICE HISTORY REVIEW (DHR) OF THE REPORTED LOT 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 THE APPLICABLE PROCEDURE. VISUAL COMPARISON OF THE ENGINEERING DRAWING WITH THE IMPLANT VERIFIED THAT THE DESIGN WAS CONSISTENT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS WITHIN SPECIFICATIONS AND CONFORMING WHEN IT LEFT ZIMMER BIOMET. A COMPLAINT HISTORY REVIEW FOR THE REPORTED LOT CONCLUDED THAT THERE ARE NO OTHER REPORTED COMPLAINTS WITH SIMILAR INCIDENTS AGAINST THE LOT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PROBABLE CAUSE OF THE REPORTED EVENT AS IDENTIFIED IN THE RISK FILE, INCLUDES CUSTOMER ERROR DUE TO EXCESSIVE INSERTION TORQUE. 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

    IT WAS REPORTED THAT THE IMPLANT BODY WOULD NOT DISENGAGE FROM THE MOUNT. ANOTHER IMPLANT WAS PLACED DURING THE SAME SURGERY. TOOTH LOCATION 30.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT'S AGE NOT PROVIDED/UNKNOWN. PATIENT'S WEIGHT NOT PROVIDED/UNKNOWN. ADDITIONAL 510K NUMBER: K962106. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT BODY WOULD NOT DISENGAGE FROM THE MOUNT. ANOTHER IMPLANT WAS PLACED DURING THE SAME SURGERY. TOOTH LOCATION 30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838916 IMPL TWIST MP-1 5.0 MM 10 MM DENTAL IMPLANT DZE ZIMMER DENTAL 63396609

    Patients

    Seq Age Sex Outcome Treatment
    1