BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,8

    MDR report key: 13413410 · Received February 1, 2022

    Report

    Report Number
    0002023141-2022-00213
    Event Type
    Injury
    Date Received
    February 1, 2022
    Date of Event
    January 1, 2020
    Report Date
    July 19, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019263
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES'. AN IMP,TSV,4.1MM,SBM,8 (TSV4B8) AND AN UNK ZIMMER SCREW WERE RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCTS IDENTIFIED BONE / TISSUE ATTACHED TO THE IMPLANT EXTERNAL THREADS. FRACTURE AT THE COLLAR AND SCREW FRACTURE FOUND INSIDE. NO PRE-EXISTING CONDITIONS NOTED ON THE PER. THE REPORTED DEVICE WAS LOCATED ON TOOTH #36 AND WAS USED FOR APPROXIMATELY 4 YEARS. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE FOR ZIMMER DENTAL IMPLANT SYSTEMS (4894 REV 6 - 08/19) INFORMATION IDENTIFIED: 'PRECAUTIONS' 'BREAKAGE' 'WARNING' REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE FOR SCREW-VENT® IMPLANTS (9665 REV 0-09/14) INFORMATION IDENTIFIED: CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, BREAKAGE. DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1240146). 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: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1240146) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. . POST MARKET TREND REVIEW: MAY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREW AND IMPLANT HEAD FRACTURED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487414 IMP,TSV,4.1MM,SBM,8 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B8 1240146 00889024019263

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention