BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSVMWB11

    MDR report key: 7933675 · Received October 4, 2018

    Report

    Report Number
    0001038806-2018-00857
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Date of Event
    September 5, 2018
    Report Date
    January 23, 2019
    Manufacturer
    ZIMMER DENTAL-2023411
    Product Code
    DZE
    PMA / PMN Number
    PK111889
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO SUPPLEMENT. THE REPORTED DEVICE, ONE TAPERED SCREW VENT IMPLANT, WAS RETURNED FOR EVALUATION ALONG WITH THE CORRESPONDING TRANSFER MOUNT AND RETAINING SCREW. VISUAL INSPECTION REVEALED MINIMUM WEAR ABOUT THE THREADS, COLLAR, AND VENT. THE MOUNT SCREW SHOWS SOME SIGNS OF WEAR. THE DEVICES ARE NOTED TO ALREADY BE SEPARATED. THE INTERNAL DRIVE FEATURE OF THE IMPLANT CONTAINS A SIGNIFICANT AMOUNT OF DEBRIS. FUNCTIONAL TESTING REVEALED THAT THE SCREW AND MOUNT HEX WERE ABLE TO BE ASSEMBLED AND DISENGAGED WITH HAND LOOSENING TORQUE IN THEIR RETURNED CONDITION. THE REPORTED CONDITION OF THE IMPLANT MOUNT COULD NOT BE REMOVED WAS NOT CONFIRMED. A DEVICE HISTORY REVIEW (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO NON-CONFORMANCES WHICH COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT WERE DOCUMENTED. BASED ON INSPECTION OF RELEVANT DHR INFORMATION, THE REPORTED IMPLANT LIKELY LEFT THE ZIMMER BIOMET MANUFACTURING SITE CONFORMING AND WITHIN SPECIFICATIONS. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. PROBABLE CAUSES FOR THE EVENT INCLUDE EXCESSIVE INSERTION TORQUE AND PATIENT SPECIFIC ISSUES THAT COULD CONTRIBUTE TO MOUNT DEFORMATION, SUCH AS UNTAPPED DENSE BONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DOCTOR INDICATED THAT THE SCREW MOUNT DOES NOT DISENGAGE FROM THE IMPLANT IN THE MOUTH OF THE PATIENT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. THE SCREW MOUNT WAS UNSCREWED AFTER INTERVENTION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510K;101880. (B)(4).

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT THE SCREW MOUNT DOES NOT DISENGAGE FROM THE IMPLANT (TSVMWB11) IN THE MOUTH OF THE PATIENT. THE DOCTOR REMOVED THE IMPLANT AND PLACED ANOTHER ONE. THE SCREW MOUNT WAS UNSCREWED AFTER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775010 TSVMWB11 SCREW MOUNT DZE ZIMMER DENTAL-2023411 63712754

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR