BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,10

    MDR report key: 13117175 · Received December 30, 2021

    Report

    Report Number
    0002023141-2021-03737
    Event Type
    Injury
    Date Received
    December 30, 2021
    Date of Event
    October 26, 2021
    Report Date
    June 27, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019225
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES.' H4: DEVICE MANUFACTURE DATE NOT AVAILABLE, LOT NUMBER UNKNOWN. H10: ADDITIONAL NARRATIVE: AN IMP,TSV,4.1MM,SBM,10 (TSV4B10) WAS RETURNED FOR INVESTIGATION IN THE COMPLAINT. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WORN MARKINGS DUE TO USAGE. MOUNT FRACTURED AT HEX. NO MALFUNCTION TO THE IMPLANT. PRE-EXISTING PATIENT FACTORS, X-RAY, TOOTH LOCATION ARE NOT RELEVANT TO THE REPORTED EVENT. THE LENGTH OF USAGE OF THE DEVICE IS SAME DAY. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT®, ADVENT® AND TRABECULAR METAL¿ IMPLANTS 4869 REV 9-10/19. INFORMATION IDENTIFIED: 'CONTRAINDICATIONS' 'WARNINGS' 'CHANGES IN PERFORMANCE' 'ADVERSE EFFECTS' DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1240277). 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 (1240277) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: FRACTURE MOUNT. POST MARKET TREND REVIEW: APRIL 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.

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    DOCTOR REPORTED THAT IMPLANT'S HEXAGONAL BROKE OFF WHEN PLACING IT UNDER 30 NCM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018807 IMP,TSV,4.1MM,SBM,10 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B10 1240277 00889024019225

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention