BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCATOR ABUTMENT

    MDR report key: 15638473 · Received October 20, 2022

    Report

    Report Number
    0001038806-2022-01589
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Report Date
    November 10, 2022
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZEST PER # 22-1071 ((B)(4)). THE COMPLAINT AND PRODUCT ASSOCIATED WAS RECEIVED, REVIEWED, AND EVALUATED BY THE MANUFACTURER. VISUAL INSPECTION OF THE RETURNED ABUTMENT FOUND THAT THE ABUTMENT WAS FRACTURED. THERE IS NO MANUFACTURING DEFECT NOTED. NO MANUFACTURER'S DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. IT WAS REPORTED THAT THE SCREW OF A LOCATOR ABUTMENT FRACTURED. THE REPORTED COMPLAINT WAS CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. HOWEVER, THE MOST LIKELY CAUSE TYPICALLY IS THE RESULT FROM INSUFFICIENT TIGHTENING TORQUE AT PLACEMENT, OVERLOADING OF THE ABUTMENT IN FUNCTION, OR NOT RETIGHTENING THE ABUTMENT AT PRESCRIBED INTERVALS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). DATE OF EVENT UNKNOWN / NOT PROVIDED. BRAND NAME UNKNOWN / NOT PROVIDED. CATALOG, LOT NUMBER, EXPIRATION DATE AND UNIQUE IDENTIFIER (UDI) NUMBER UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER NOT AVAILABLE. DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED. ITEM AND LOT NUMBER WAS NOT PROVIDED AND THE ITEM IS NOT BEING RETURNED. THEREFORE, WITH THE INFORMATION PROVIDED, NO FURTHER INVESTIGATION CAN BE CARRIED OUT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LOCATOR SCREW FRACTURED IN THE PATIENT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2494653 LOCATOR ABUTMENT DZE BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male