BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATUM FOOT PLATING SYSTEM

    MDR report key: 11022161 · Received December 16, 2020

    Report

    Report Number
    3009540749-2020-00048
    Event Type
    Injury
    Date Received
    December 16, 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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED A REVISION SURGERY OCCURRED ON AN UNKNOWN DATE DUE TO A NON-UNION INVOLVING A STRATUM LAPIDUS PLATE. NO ADDITIONAL INFORMATION OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485168 STRATUM FOOT PLATING SYSTEM PLATE HRS NEXTREMITY SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention