BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,11.5

    MDR report key: 16245313 · Received January 26, 2023

    Report

    Report Number
    0002023141-2023-00301
    Event Type
    Injury
    Date Received
    January 26, 2023
    Date of Event
    November 4, 2022
    Report Date
    April 13, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019232
    PMA / PMN Number
    K072589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER CMP-0853898 THE FOLLOWING SECTIONS HAVE BEEN UPDATED: D9: DEVICE AVAILABLE FOR EVALUATION CHANGE ¿NO' TO 'YES.' H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES.' PRODUCT EVALUATION: ONE IMPLANT AND MOUNT WERE RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED BONE DEBRIS AND A FRACTURED MOUNT. THE MOUNT WAS FRACTURED AT THE HEX. THE HEX PIECE WAS RETURNED WITH THE MOUNT AND IMPLANT. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT (FRACTURED MOUNT). A PRE-EXISTING CONDITION WAS NOT NOTED ON THE PER FORM. BONE DENSITY WAS UNKNOWN. THE REPORTED DEVICE WAS LOCATED AT AN UNKNOWN TOOTH LOCATION. THE DEVICE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. X-RAY & PICTURE EVALUATION: THE CUSTOMER DID NOT PROVIDE ANY IMAGES FOR THE REPORTED EVENT. 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 1254577. 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 1254577 FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: 'DENTAL : FUNCTIONAL : FRACTURE : MOUNT.' POST MARKET TREND REVIEW: JANUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. 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 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

    DOCTOR REPORTED MOUNT FRACTURE. NO PATIENT IMPACT. THE PROCEDURE HAS BEEN COMPLETED WITH ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823271 IMP,TSV,4.1MM,SBM,11.5 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B11 1254577 00889024019232

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male