BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® TITANIUM HEXED SCREW

    MDR report key: 6556466 · Received May 10, 2017

    Report

    Report Number
    0001038806-2017-00214
    Event Type
    Malfunction
    Date Received
    May 10, 2017
    Date of Event
    April 20, 2017
    Report Date
    August 23, 2017
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    PK072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: CHANGED TO CERTAIN® TITANIUM HEXED SCREW. CHANGED CATALOG NUMBER FROM IUNIHG TO IUNIHT.

    Additional Manufacturer Narrative · 1

    FOLLOWING THE INVESTIGATION ON THE RETURNED PRODUCT THAT WAS PERFORMED ON AUGUST 22, 2017, IT WAS FOUND THAT THE DEVICE WAS NOT MANUFACTURED BY ZIMMER BIOMET. AS A RESULT, THE PRIOR SUBMISSIONS FOR MFR- 0001038806-2017-00214, SUBMITTED ON MAY 10, 2017, AND MFR- 0001038806-2017-00214-1, SUBMITTED ON AUGUST 10, 2017, ARE NO LONGER CONSIDERED REPORTABLE EVENTS BY THE MANUFACTURE AND NO FURTHER REPORTS WILL BE SUBMITTED. THE DEVICE IS A COMPETITOR PRODUCT. UPON VISUAL INSPECTION DURING THE INVESTIGATION, THE ABUTMENT SCREW COULD NOT BE IDENTIFIED AS A ZIMMER BIOMET. THIS IS BEING SUBMITTED AS ADDITIONAL INFORMATION TO THE PRIOR REPORT AFTER CONFIRMING THAT THIS WAS NOT A ZIMMER BIOMET PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE LOT # WAS NOT PROVIDED/UNKNOWN. PRODUCT NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ARRIVED AT DENTAL OFFICE WITH A LOOSE CROWN. AS THE DENTIST WAS TORQUING THE SCREW THEN IT FRACTURED AND THE HEAD OF THE SCREW CAME OFF. FRAGMENTS OF SCREW REMAIN IN THE IMPLANT. IT WAS ORIGINALLY PLACED 4 YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339028 CERTAIN® TITANIUM HEXED SCREW ABUTMENT SCREW NHA BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1