BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,13,MTX,MG

    MDR report key: 8841652 · Received July 30, 2019

    Report

    Report Number
    0002023141-2019-00484
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    June 18, 2019
    Report Date
    November 11, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMP,TSV,3.7,13,MTX,MG (TSVTB13) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WEAR ABOUT THE IMPLANT THREADS, AND DEBRIS WITHIN THE DRIVE FEATURE. THE PRODUCT MATCHED PRINT SPECIFICATIONS WHERE MEASURED AGAINST DRAWING PD-TSVTB13 REV B. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 4 AND USED FOR APPROXIMATELY 5 MONTHS PRIOR TO REMOVAL. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE PRODUCT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1223374. 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. STERILIZATION RECORD (OP150) WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1223374) FOR SIMILAR CAUSE AND NO OTHER COMPLAINT WAS IDENTIFIED. AUGUST POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS (MOBILITY + PAIN + BONE LOSS +INFECTION) OR PRODUCT (TSVTB13). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS NOT OCCURRED AND THE REPORTED EVENT WAS NON-VERIFIABLE. A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED. D4: UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). DATE OF BIRTH UNKNOWN. WEIGHT UNKNOWN. FIRST NAME UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED IMPLANT MOBILITY, PAIN, BONE LOSS AND INFECTION. THE SITE WAS GRAFTED AND THE PATIENT WAS GIVEN ANTIBIOTICS. TOOTH LOCATION 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635955 IMP,TSV,3.7,13,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1223374

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention