BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0 SYSTEM 2.0/1.0 4 HOLE XLONG PLATE

    MDR report key: 19193220 · Received April 26, 2024

    Report

    Report Number
    0001032347-2024-00134
    Event Type
    Injury
    Date Received
    April 26, 2024
    Date of Event
    April 30, 2019
    Report Date
    April 26, 2024
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    K121589
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). D10 ¿ MEDICAL PRODUCTS ITEM # 91-2011, LOT # NI; 2.0MM SYSTEM 2.0X11MM HT X-DRIVE SCREW. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT'S ACTIVITY LEVEL WAS DESCRIBED AS SEDENTARY AND HAD A MEDICAL HISTORY THAT INCLUDES FACIAL ASYMMETRY. THE PLATES WERE REMOVED DUE TO EXPOSURE OF THE PLATE, NOT AN ACTIVE INFECTION. THE MEDICAL RECORDS WERE PARTIALLY LEGIBLE DUE TO POOR PICTURE QUALITY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT WAS NOTED THIS PATIENT HAD A MEDICAL HISTORY THAT INCLUDES FACIAL ASYMMETRY. IT COULD NOT BE DETERMINED IF THIS CONDITION CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED EVENT IS UNCONFIRMED. 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 THE PATIENT WAS REVISED UNDER LOCAL ANESTHESIA DUE TO PLATE EXPOSURE IN THE MOUTH, NOT AN ACTIVE INFECTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870551 2.0 SYSTEM 2.0/1.0 4 HOLE XLONG PLATE PLATE, BONE JEY BIOMET MICROFIXATION N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Hospitalization| R SEE H10