BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SP 3.7MM 12M M HEXAGON

    MDR report key: 8599965 · Received May 10, 2019

    Report

    Report Number
    0002023141-2019-00208
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 6, 2019
    Report Date
    August 22, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K082639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SP 3.7MM 12M M HEXAGON (SPMB12) WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED MINIMAL WEAR ABOUT THE IMPLANT THREAD, COLLAR, DRIVE FEATURE, AND MOUNT HEX. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS AGAINST THIS LOT. APPROPRIATE DOCUMENTATION WAS REVIEWED. 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. FUNCTIONAL TESTING WAS PERFORMED FOR THE RETURNED PRODUCT AND IT WAS DETERMINED THAT THE MOUNT WAS ABLE TO BE REMOVED WITH TSVKIT HAND TOOLS. THE ALLEGED DEVICE MALFUNCTION WAS UNCONFIRMED. A ROOT CAUSE CANNOT BE IDENTIFIED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT D4: DEVICE EXPIRATION D4: (B)(4). G4: DATE RECEIVED BY MANUFACTURER G7: CHECKED "FOLLOW-UP" H2: CHECKED FOLLOW-UP TYPE H3: CHANGED "NO" TO "YES" H4: DATE OF MANUFACTURE H6: ENTERED EVALUATION CODES H10: ADDED MANUFACTURER NARRATIVE

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT. ADDITIONAL 510K NUMBERS: K011245 AND K002188.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUNDLED IMPLANT AND MOUNT (SPMB12) WOULD NOT DISENGAGE FROM EACH OTHER. ANOTHER IMPLANT WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394436 IMPL TAPERED SP 3.7MM 12M M HEXAGON DENTAL IMPLANT DZE ZIMMER DENTAL 63767570

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR