BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MICROFIXATION FACIAL PLATING SYSTEM

    MDR report key: 6567541 · Received May 15, 2017

    Report

    Report Number
    0001032347-2017-00390
    Event Type
    Injury
    Date Received
    May 15, 2017
    Date of Event
    April 3, 2017
    Report Date
    January 10, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK121589
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE REPORT 0001032347-2017-00388.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS IN PROGRESS, A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. SUPPLEMENTAL REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE REPORT 0001032347-2017-00388-1.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PRODUCTS WERE RETURNED WITHOUT PACKAGING. THE SCREWS WERE VISUALLY EVALUATED AND FOUND TO HAVE BEEN FRACTURED. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. THE COMPLAINT WAS CONFIRMED AS THE SCREWS WERE FOUND TO BE FRACTURED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO EXCESSIVE FORCE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THE FOLLOWING SECTIONS WERE UPDATED: DATE OF THIS REPORT, DATE RECEIVED BY MANUFACTURER, TYPE OF REPORT AND FOLLOW-UP NUMBER, TYPE OF FOLLOW-UP, DEVICE EVALUATED BY MANUFACTURER, ADDITIONAL NARRATIVES/ DATA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2017-00388-2.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TUMOR REMOVAL EIGHT SCREWS BROKE DURING INSERTION. THERE WAS A FORTY MINUTE SURGICAL DELAY. THE BODY OF THE SCREWS REMAIN IN THE PATIENT'S SKULL. THE SAME SIZE SCREWS WERE USED TO COMPLETE THE SURGERY, HOWEVER THEY WERE IMPLANTED IN DIFFERENT LOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348826 BIOMET MICROFIXATION FACIAL PLATING SYSTEM BONE SCREW; 1.5X5MM HT SD X-DRIVE SCREW JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention| S