BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11320739 · Received February 12, 2021

    Report

    Report Number
    0002023141-2021-00380
    Event Type
    Injury
    Date Received
    February 12, 2021
    Date of Event
    January 4, 2021
    Report Date
    June 2, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019621
    PMA / PMN Number
    K111889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE IMP,TSV,MCOL MG,4.1MM,10M (TSVM4B10) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED MINOR DRIED BONE AROUND THE IMPLANT BODY AND DAMAGE FROM REMOVAL AROUND THE IMPLANT THREADS AND COLLAR. IMPLANT THREADS AND COLLAR DAMAGE OBSERVED DURING INSPECTION LIKELY RESULTED FROM THE IMPLANT REMOVAL PROCESS AFTER THE REPORTED BONE FRACTURE EVENT. THE DAMAGE FOUND ISN'T A FAILURE OF THE REPORTED DEVICE RELATED TO THE REPORTED EVENT AND DEVICE MALFUNCTION COULD NOT BE VERIFIED DUE TO THE CONDITION OF THE RETURNED DEVICE. PRODUCT MATCHED PRINT SPECIFICATION WHERE MEASURED. A PRE-EXISTING CONDITION NOTED ON THE PER WAS THAT THE PATIENT WAS A SMOKER. ADDITIONALLY, THE PATIENT HAD MODERATE (TYPE II) BONE DENSITY AND THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 36 (FDI) AND WAS REMOVED THE SAME DAY AS PLACEMENT. DEVICE HISTORY REVIEW (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1231607. 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 WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1231607) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED DUE TO THE CONDITION OF THE RETURNED DEVICE, AS THE IMPLANT IS NOTED TO HAVE DAMAGE FROM REMOVAL AROUND THE IMPLANT THREADS AND COLLAR. ADDITIONALLY, THE REPORTED EVENT WAS NON-VERIFIABLE WITH THE INFORMATION PROVIDED AND NO X-RAYS TO EVALUATE THE BONE FRACTURE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PLACEMENT THE BONE FRACTURED. IMPLANT WAS REMOVED AND DOCTOR DID NOT PLACE ANOTHER IMPLANT IN THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222297 IMP,TSV,MCOL MG,4.1MM,10M DENTAL IMPLANT DZE ZIMMER DENTAL TSVM4B10 1231607 00889024019621

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention