BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,16,MTX,MG

    MDR report key: 16239977 · Received January 25, 2023

    Report

    Report Number
    0002023141-2023-00284
    Event Type
    Injury
    Date Received
    January 25, 2023
    Date of Event
    October 26, 2022
    Report Date
    May 24, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019959
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE (1) IMP,TSV,3.7,16,MTX,MG (TSVTB16) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED IMPLANT IDENTIFIED SIGNS OF USE, APPARENT MINOR BONE ATTACHED TO EXTERNAL THREADS. SCREW FRAGMENT IDENTIFIED IN DRIVE FEATURE - POSSIBLY THE MOUNT SCREW. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. A PRE-EXISTING CONDITION NOTED ON THE PER WAS HIGH BONE DENSITY (TYPE I). THE REPORTED IMPLANT WAS LOCATED ON TOOTH # 21 (UNIVERSAL) AND WAS USED, PLACED AND REMOVED ON THE SAME DAY. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1254032). 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. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1254032) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. MARCH POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS (DOES NOT DISENGAGE/RELEASE & FRACTURE MOUNT) OR PRODUCT (TSVTB16). NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR, AND THE REPORTED EVENT (FRACTURE MOUNT) WAS CONFIRMED SINCE, THE MOUNT SCREW WAS SEEN STUCK IN THE IMPLANT'S DRIVE FEATURE. HOWEVER, DEVICE MALFUNCTION AND THE REPORTED EVENT (DOES NOT DISENGAGE/RELEASE) WAS NON-VERIFIABLE WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT IN SITE 21 WAS REMOVED DUE TO SCREW HOLDING TRANSFER COPING WOULD NOT LOOSEN AND THEN THE COPING BROKE. HAD TO CUT OUT AND TREPHINE IMPLANT FROM BONE. IMPLANT PLACED IN ADJACENT LOCATION. SITE GRAFTED. ALLOGRAFT PLACED WITH IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202954 IMP,TSV,3.7,16,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTB16 1254032 00889024019959

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention