BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLAT TITANIUM PECTUS BAR 11IN

    MDR report key: 21112719 · Received January 9, 2025

    Report

    Report Number
    0001032347-2025-00008
    Event Type
    Injury
    Date Received
    January 9, 2025
    Report Date
    June 4, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036179106
    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. 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. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; D4; G1; G3; G6; H1; H2; H3; H4; H6; H10. THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO K212841. THE REPORTED EVENT IS UNCONFIRMED. 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 RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10 ¿ MEDICAL PRODUCTS. ITEM# JP-0110, LOT# 66708431, FLAT TITANIUM PECTUS BAR 11IN.

    Description of Event or Problem · 0

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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367411 FLAT TITANIUM PECTUS BAR 11IN PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A 66749630 00841036179106

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Unknown Other SEE H10.