BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,10,MTX,MG

    MDR report key: 16245333 · Received January 26, 2023

    Report

    Report Number
    0002023141-2023-00303
    Event Type
    Injury
    Date Received
    January 26, 2023
    Date of Event
    November 14, 2022
    Report Date
    May 8, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019928
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM D4: ADDITIONAL DEVICE INFORMATION G3: DATE RECEIVED BY MANUFACTURER G6: TYPE OF REPORT H1: TYPE OF REPORTABLE EVENT H2: FOLLOW UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER H4: DEVICE MANUFACTURER DATE H6: ADVERSE EVENT PROBLEM H10: ADDITIONAL NARRATIVE. ONE TAPERED SCREW-VENT IMPLANT (TSVTB10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED A FRACTURED COLLAR ON THE IMPLANT AND BONE DEBRIS AROUND THE EXTERNAL THREADS DUE TO USAGE. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. PRE-EXISTING CONDITIONS NOTED ON THE PER WERE POOR BONE DENSITY ¿ TYPE IV & ORAL HYGIENE. THE REPORTED IMPLANT HAD BEEN PLACED ON TOOTH #36 (FDI) FOR APPROXIMATELY 1 YEAR. DHR REVIEW FOR THE LOT (1243249) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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 LOT (1243249) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED (KEYWORD USED: FRACTURE: IMPLANT). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR, AND THE REPORTED EVENT WAS CONFIRMED.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DENTAL IMPLANT FAILED BECAUSE IT FRACTURED AT THE HEAD. THE PROCEDURE WAS CONCLUDED WITH THE PLACEMENT OF ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943170 IMP,TSV,3.7,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTB10 1243249 00889024019928

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention