BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATUM FOOT PLATING SYSTEM

    MDR report key: 11021434 · Received December 16, 2020

    Report

    Report Number
    3009540749-2020-00047
    Event Type
    Injury
    Date Received
    December 16, 2020
    Date of Event
    November 24, 2020
    Report Date
    December 16, 2020
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    HRS
    PMA / PMN Number
    K182201
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS RELATED TO THE EVENT WERE REVIEWED. THERE WERE NO NON-CONFORMANCES DETECTED THROUGH THE DEVICE HISTORY RECORD REVIEW. ROOT CAUSE IS UNKNOWN. IF ADDITIONAL INFORMATION IS OBTAINED WHICH CHANGES THE OUTCOME OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH A STRATUM STRAIGHT PLATE- 5 HOLE ON (B)(6) 2020. THEN ON (B)(6) 2020 PATIENT UNDERWENT A REVISION SURGERY DUE TO A NON-UNION. SURGEON REVISED THE CASE USING A INTERFRAG SCREW, BONUS TRIAD AND A NEW STRATUM LAPIDUS PLATE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485123 STRATUM FOOT PLATING SYSTEM PLATE HRS NEXTREMITY SOLUTIONS M1827

    Patients

    Seq Age Sex Outcome Treatment
    1