BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW NOBEL RE TI 3.5

    MDR report key: 8399411 · Received March 7, 2019

    Report

    Report Number
    0001038806-2019-00170
    Event Type
    Injury
    Date Received
    March 7, 2019
    Report Date
    June 13, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K120873
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: CORRECTION: ADVERSE EVENT IT WAS REPORTED THAT A ZFX GMBH SCREW FRACTURED. THE SCREW WAS RE-TIGHTENED AT 20 NMC. THE FRACTURED PART OF THE SCREW REMAINS INSIDE THE IMPLANT. THE IMPLANT WAS REMOVED. THERE WAS NO REPORT OF PATIENT HARM. CORRECTION: SCREW NOBEL RE TI 3.5 (B)(6) 2019 FOLLOW UP CORRECTION: SERIOUS INJURY CORRECTION METHOD, DEVICE, CONCLUSION CODES MANUFACTURER NARRATIVE, CORRECTED DATA INVESTIGATION OF THE REPORTED DEVICE IS THE RESPONSIBILITY OF THE SUPPLIER. DUE DILIGENCE HAS BEEN COMPLETED TO OBTAIN INVESTIGATION RESULTS BY THE SUPPLIER AND RESULTS HAVE NOT BEEN RECEIVED TO DATE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A ZFX GMBH SCREW FRACTURED WITHIN A BIOMET IMPLANT. THE SCREW WAS RETIGHTENED AT 20 NMC. THE FRACTURED PART OF THE SCREW REMAINS INSIDE THE IMPLANT. THE IMPLANT WAS REMOVED. THERE WAS NO REPORT OF PATIENT HARM.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO REPORT ZIMMER BIOMET COMPLAINT (B)(4). THERAPY DATE: UNKNOWN, MEDICAL PRODUCT- BIOMET CERTAIN OSSEOTITE IMPLANT, ITEM # XIFOSS411 LOT #: 2017061036. 510K: K072642. THE FOLLOWING INFORMATION IS UNKNOWN AT THE TIME OF THIS REPORT. PHONE NUMBER NOT PROVIDED. DEVICE MFR DATE: UNKNOWN. THE REPORTED DEVICE WILL NOT BE RETURNED FOR ANALYSIS; AS IT REMAINS IMPLANTED IN THE PATIENT'S MOUTH. AN INVESTIGATION OF THE REPORTED EVENT WILL BE COMPLETED. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DR THAT ONE OF THE TWO SCREWS THAT WERE HOLDING A MILLED PROSTHESIS FRACTURED. THE SCREWS WERE TIGHTENED AT 20 NMC. THE FRACTURED PART OF THE SCREW REMAINS INSIDE THE IMPLANT. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191259 SCREW NOBEL RE TI 3.5 TITANIUM SCREW NHA BIOMET 3I N/A 170320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention