BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PECTUS SYSTEM DEFAZIO 13 TI PECTUS BAR

    MDR report key: 9746472 · Received February 24, 2020

    Report

    Report Number
    0001032347-2020-00126
    Event Type
    Injury
    Date Received
    February 24, 2020
    Date of Event
    February 5, 2020
    Report Date
    July 29, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036261436
    PMA / PMN Number
    K061384
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED AS THERE WAS A REVISION SURGERY. THE PECTUS BARS REMAIN IMPLANTED AND WERE NOT RETURNED FOR INVESTIGATION. THE DHR WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT IS PATIENT CONDITION. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED; 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 REPORTS: 0001032347-2020-00127. CONCOMITANT MEDICAL PRODUCTS: PECTUS SYSTEM DEFAZIO 13 TI PECTUS BAR, PART# PT-2872, LOT# 885100. PECTUS SYSTEM DEFAZIO 13.5 TI PECTUS BAR, PART# PT-2873, LOT# 885110.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY ONE YEAR FOLLOWING IMPLANTATION OF TWO CUSTOM PECTUS BARS. THE PATIENT WAS INVOLVED IN A CAR ACCIDENT AND THE BARS NEEDED TO BE RE-POSITIONED. THE RE-OPERATION WAS SUCCESSFUL AND THE PATIENT IS DOING WELL. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207961 PECTUS SYSTEM DEFAZIO 13 TI PECTUS BAR PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A 885100 00841036261436

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R SEE H10 NARRATIVE.