BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLAT TITANIUM PECTUS BAR 10.5

    MDR report key: 21585960 · Received March 12, 2025

    Report

    Report Number
    0001032347-2025-00123
    Event Type
    Injury
    Date Received
    March 12, 2025
    Report Date
    June 4, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036189297
    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

    COMPLAINT (B)(4). G2: FOREIGN SOURCE: JAPAN. D10 ¿ MEDICAL PRODUCTS ITEM# JP-0105, LOT# 65693934, FLAT TITANIUM PECTUS BAR 10.5IN. ITEM# JP-0110, LOT# 66708431, FLAT TITANIUM PECTUS BAR 11IN. 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.

    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.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE PATIENT UNDERWENT A PECTUS BAR IMPLANTATION FOR FUNNEL CHEST TREATMENT. SUBSEQUENTLY IMMEDIATELY AFTER HOSPITAL DISCHARGE, THE PATIENT WAS SEEN AT AN OUTPATIENT CLINIC WITH FEVER DUE TO UNKNOWN REASONS. PATIENT RECEIVED ANTIBIOTICS AND PREDNISONE AND RECOVERED WELL.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT DETAILS ARE AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434268 FLAT TITANIUM PECTUS BAR 10.5 PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION 65693936 00841036189297

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Unknown Other SEE H11.