BEUDAMED
    FDA Adverse Event Injury Summary report: N

    "1.5MM" SYSTEM PLATE 1.5 2 HOLE LONG STRAIGHT

    MDR report key: 15977990 · Received December 14, 2022

    Report

    Report Number
    0001032347-2022-00382
    Event Type
    Injury
    Date Received
    December 14, 2022
    Date of Event
    November 16, 2022
    Report Date
    February 23, 2023
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    K121589
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT: (B)(4). REPORT SOURCE: JAPAN. CONCOMITANT MEDICAL PRODUCT(S): ITEM# 95-6104, LOT# NI, PRODUCT TYPE: "1.5MM" SYSTEM 1.5X4MM HT SD X-DR SCR 5-PK. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2022-00389.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 IS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE OF A SCREW AND PLATE DUE TO AN ALLERGIC REACTION. THE PATIENT HAD POOLING OF FLUID UNDER THE SKIN THAT CAUSED THE SCREW TO FLOAT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2052529 "1.5MM" SYSTEM PLATE 1.5 2 HOLE LONG STRAIGHT PLATE, BONE JEY BIOMET MICROFIXATION N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R