BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SP 3.7MM 8MM OCTAGON

    MDR report key: 8655550 · Received May 30, 2019

    Report

    Report Number
    0002023141-2019-00228
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    March 22, 2019
    Report Date
    August 26, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K082639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WEAR AND DEBRIS ABOUT THE IMPLANT THREADS. THE INTERNAL DRIVE FEATURE IS NOTED TO CONTAIN A SMALL PIECE OF THE FRACTURED SCREW REPORTED, WHICH WAS TOO BADLY DAMAGED TO BE REMOVED. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 47 (FDI) AND WAS REMOVED THE SAME DAY. REVIEW OF APPROPRIATE DOCUMENTATION: ¿INSTRUCTIONS FOR USE FOR SWISSPLUS® AND TAPERED SWISSPLUS® IMPLANTS¿ 9967 REV 0-09/14; TECHNIQUE INFORMATION ¿ STEP 6 COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (62741073) FOR SIMILAR CAUSE AND NO OTHER COMPLAINT WAS IDENTIFIED. MAY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (MOUNT SCREW FRACTURE) OR PRODUCT (SPB8) THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA/HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE 'NO' TO 'YES'.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PMA/510(K) NUMBER K011245/K002188.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOUNT SCREW FRACTURED INSIDE THE IMPLANT CAUSING IMPLANT TO BE REMOVED AND REPLACED. THERE WAS A 40 MINUTE DELAY IN SURGERY. TOOTH LOCATION 47.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449024 IMPL TAPERED SP 3.7MM 8MM OCTAGON IMPLANT DZE ZIMMER DENTAL 62741073

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR