BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN GOLD-TITE TM HEXED SCREW

    MDR report key: 6668683 · Received June 26, 2017

    Report

    Report Number
    0001038806-2017-00346
    Event Type
    Malfunction
    Date Received
    June 26, 2017
    Report Date
    November 8, 2017
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    PK072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED AND NOT RETURNED TO THE MANUFACTURER. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    ONE SCREW WAS RECEIVED AT PBG ON (B)(6) 2017 AS REPORTED IN MFR-0001038806-2017-00346-1 SUBMITTED ON AUGUST 21, 2017, SCREW HAS NO HEX TOP REMAINING. HOWEVER, SUBJECT PRODUCT HAS BEEN MISPLACED IN HOUSE AND IS NOT AVAILABLE FOR FURTHER EVALUATION BY THE INVESTIGATOR. NO DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: BIOMET 3I RESTORATIVE MANUAL INSTRM REV D 06/17 INFORMATION IDENTIFIED: THE BIOMET 3I RESTORATIVE MANUAL WAS CONFIRMED TO CONTAIN INSTRUCTION ON SCREW PLACEMENT AS WELL AS RECOMMENDED TORQUE VALUES. IN THE CASE OF CERTAIN GOLD-TITE HEXED SCREW IT IS RECOMMENDED TO TORQUE AT 20NCM. COMPLAINT INDICATED ¿THAT THE IUNIHG SCREW BROKE INSIDE OF THE PATIENT¿S MOUTH¿. BASED ON THE CONDITION OF THE RETURNED DEVICE; THE REPORTED EVENT IS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IUNIHG ABUTMENT SCREW BROKE INSIDE OF THE PATIENTS MOUTH. A PORTION OF IT REMAINS WITHIN THE IMPLANT AND THE PATIENT WILL RETURN FOR THE SCREW REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448282 CERTAIN GOLD-TITE TM HEXED SCREW ABUTMENT SCREW NHA BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1