BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PECTUS BLU PRBNT TI BAR 12IN

    MDR report key: 22680348 · Received July 31, 2025

    Report

    Report Number
    0001032347-2025-00335
    Event Type
    Injury
    Date Received
    July 31, 2025
    Date of Event
    August 16, 2024
    Report Date
    July 31, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K212841
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: UDI - THERE ARE MULTIPLE UDIS THAT COULD BE APPLICABLE: (B)(4). H4: MANUFACTURING DATE - THERE ARE MULTIPLE MANUFACTURING DATES THAT COULD BE APPLICABLE: ZIMMER LOTS 191530, 191540: AUG 24, 2023, ZIMMER LOT: 178570: MAY 17, 2023, ZIMMER LOT: 178560: MAY 9, 2023. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: DURING FOLLOW-UP, PATIENT REPORTS DAILY RIPPING FEELING IN HIS CHEST AND XRAY SHOWS MIGRATION OF CAUDAL BAR TO THE LEFT. BAR REVISION OCCURRED WITH ADDITION OF STABILIZER. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE REPORTED EVENT IS CONFIRMED BY PROVIDED MEDICAL RECORDS. 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 THE PATIENT UNDERWENT AN INITIAL NUSS PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY NINE (9) MONTHS POST-IMPLANTATION DUE TO PAIN AND BAR MIGRATION. THE DEVICES REMAINED IMPLANTED, AND AN ADDITIONAL STABILIZER BAR WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197622 PECTUS BLU PRBNT TI BAR 12IN PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION 28363

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Hospitalization| R