BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,MCOL MG,4.7MM,10M

    MDR report key: 8334938 · Received February 13, 2019

    Report

    Report Number
    0001038806-2019-00102
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Date of Event
    January 16, 2019
    Report Date
    May 28, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B5: IT WAS REPORTED THAT THE IMPLANT PLACEMENT AND FIXTURE MOUNT BROKE DURING A PROCEDURE TO PLACE A TSVMWB10 IMPLANT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER IMPLANT. THERE WAS NOT REPORT OF PATIENT IMPACT. D4: EXPIRATION DATE: 31 AUG 2022 G4: 28 MAY 2019 THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE IDENTIFIED THAT THE MOUNT WAS FRACTURED AT ITS CONNECTING HEX. THE REPORTED CONDITION OF A FRACTURED IMPLANT FIXTURE MOUNT WAS CONFIRMED. 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-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 FOR SIMILAR EVENTS AND FOUR (4) OTHER COMPLAINTS WERE IDENTIFIED. ALL OF THE MOUNT FRACTURE COMPLAINTS FROM THIS LOT ARE FROM THE SAME CUSTOMER. 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

    IT WAS REPORTED THAT THE IMPLANT PLACEMENT AND FIXTURE MOUNT BROKE DURING A PROCEDURE TO PLACE A TSVMWB10 IMPLANT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER IMPLANT. THERE WAS NOT REPORT OF PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO REPORT ZIMMER BIOMET COMPLAINT (B)(4). THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION THAT REQUIRES REPORTING AND OR WHEN DEVICE INVESTIGATION IS COMPLETE. PMA/510K: PMA- K111889.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT PLACEMENT AND FIXTURE MOUNT BROKE DURING A PROCEDURE TO PLACE A TSVMWB10 IMPLANT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER IMPLANT. THERE WAS NOT REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128475 IMP,TSV,MCOL MG,4.7MM,10M DENTAL IMPLANT DZE BIOMET 3I N/A 63707484

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR