BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,MCOL MG,4.1MM,10M

    MDR report key: 18630084 · Received February 2, 2024

    Report

    Report Number
    0002023141-2024-00211
    Event Type
    Injury
    Date Received
    February 2, 2024
    Date of Event
    September 5, 2023
    Report Date
    March 28, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019621
    PMA / PMN Number
    K111889
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) TSVM4B10, (IMP,TSV,MCOL MG,4.1MM,10M) FOR EVALUATION. VISUAL EVALUATION / FUNCTIONAL TEST WAS PERFORMED, THE MOUNT COULD NOT DISENGAGE FROM THE IMPLANT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1233821. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1233821 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL : FUNCTIONAL : DOES NOT DISENGAGE/RELEASE THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RM-00541-HAZ, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS EXCESSIVE TORQUE USED TO PLACE RESTORATIVE COMPONENT OR DEBRIS STUCK IN IMPLANT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE MOUNT COULD NOT DISENGAGE FROM THE IMPLANT. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER PLACING THE IMPLANT AT TOOTH SITE 37, THE MOUNT DID NOT DISENGAGE INSTEAD OF THE DRIVER AND THE IMPLANT LOST STABILITY. THE DOCTOR WAS UNABLE TO REMOVE. NO OTHER IMPLANT WAS PLACED AND PATIENT WILL HAVE TO RETURN TO PLACE A NEW IMPLANT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255624 IMP,TSV,MCOL MG,4.1MM,10M DENTAL IMPLANT DZE ZIMMER DENTAL 1233821 00889024019621

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Required Intervention