BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLAT TITANIUM PECTUS BAR 13IN

    MDR report key: 21586208 · Received March 12, 2025

    Report

    Report Number
    0001032347-2025-00125
    Event Type
    Injury
    Date Received
    March 12, 2025
    Report Date
    June 4, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036176044
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO K212841. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS B4, B5, D4, G3, G6, H2, H3, H4, H6, H10 AND H11.

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). D10 ¿ MEDICAL PRODUCTS ITEM# JP-0125, LOT# 403640, FLAT TITANIUM PECTUS BAR 12.5 IN. ITEM# JP-0130, LOT# 65936388, FLAT TITANIUM PECTUS BAR 13 IN. G2: FOREIGN SOURCE: JAPAN. 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE PATIENT UNDERWENT A PECTUS BAR IMPLANTATION FOR FUNNEL CHEST TREATMENT. SUBSEQUENTLY ONE WEEK AFTER HOSPITAL DISCHARGED, THE PATIENT WAS SEEN WITH FEVER AND PLEURAL EFFUSION DUE TO UNKNOWN REASONS. PATIENT RECEIVED STEROIDS, ANTIBIOTICS, AND A DRAIN WAS UTILIZED TO ADDRESS FLUID IN LUNGS. THE PATIENT RECOVERED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433295 FLAT TITANIUM PECTUS BAR 13IN PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION 65936397 00841036176044

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Unknown Required Intervention SEE H11