BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,10,MTX,MG

    MDR report key: 15915870 · Received December 5, 2022

    Report

    Report Number
    0002023141-2022-03018
    Event Type
    Injury
    Date Received
    December 5, 2022
    Date of Event
    October 13, 2022
    Report Date
    March 24, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019928
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). LAST NAME UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT, B5: EVENT DESCRIPTION, G3: DATE RECEIVED BY MANUFACTURER, G6: CHECKED "FOLLOW-UP", H2: CHECKED FOLLOW-UP TYPE, H10: ADDED MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    ONE IMP,TSV,3.7,10,MTX,MG (TSVTB10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED IMPLANT IDENTIFIED FIXTURE MOUNT FRACTURED AT HEX AREA. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS FRACTURED. PRE-EXISTING CONDITION NOTED ON THE PER WAS MODERATE BONE DENSITY ¿ TYPE II. THE REPORTED DEVICE HAS BEEN PLACED ON TOOTH #29. X-RAY & PICTURE EVALUATION: X-RAY OR PICTURE IMAGE WAS NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOT (1240666) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMVIE. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1240666) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. JAN POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR, AND THE REPORTED EVENT WAS CONFIRMED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G6: CHECKED "FOLLOW-UP", H2: CHECKED FOLLOW-UP TYPE, H3: CHANGED "NO" TO "YES", H6: ENTERED EVALUATION CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS BEING TORQUED AY SITE 29 WHEN THE IMPRESSION COPING FRACTURED. THE IMPLANT WAS REMOVED AT THAT TIME. NO IMPACT TO PATIENT, NO MEDICAL HISTORY REPORTED, AND SITE WAS NOT GRAFTED.

    Description of Event or Problem · 0

    TSVTB10 MOUNT FRACTURED AND IMPLANT REMOVED.

    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
    1359280 IMP,TSV,3.7,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTB10 1240666 00889024019928

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Required Intervention