BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI MAXLOCK EXTREMEM ISO PLATES AND SCREWS

    MDR report key: 8721881 · Received June 21, 2019

    Report

    Report Number
    3004983210-2019-00030
    Event Type
    Injury
    Date Received
    June 21, 2019
    Report Date
    June 21, 2019
    Manufacturer
    TORNIER INC
    Product Code
    HRS
    PMA / PMN Number
    K101962
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOURCE OF THIS REPORT IS LITERATURE: TAKUMI MATSUMOTO, MD, PHD, CHRISTOPHER E. GROSS, MD, AND SELENE G. PAREKH, MD,MBA, SHORT-TERM RADIOGRAPHIC OUTCOME AFTER DISTAL CHEVRON OSTEOTOMY FOR HALLUX VALGUS USING INTRAMEDULLARY PLATES WITH AN AMENDED ALGORITHM FOR THE SURGICAL MANAGEMENT OF HALLUX VALGUS. FOOT & ANKLE SPECIALIST 2019, VOL. 12(1) 25-33. DOI: 10.1177/1938640018762474.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A 2019 CLINICAL STUDY FROM MATSUMOTO, ET AL., THE AUTHORS REPORT 5 CASES (13.5%) OF RESIDUAL HALLUX VALGUS DEFORMITY. SOURCE - ARTICLE: TAKUMI MATSUMOTO, MD, PHD, CHRISTOPHER E. GROSS, MD, AND SELENE G. PAREKH, MD,MBA, SHORT-TERM RADIOGRAPHIC OUTCOME AFTER DISTAL CHEVRON OSTEOTOMY FOR HALLUX VALGUS USING INTRAMEDULLARY PLATES WITH AN AMENDED ALGORITHM FOR THE SURGICAL MANAGEMENT OF HALLUX VALGUS. FOOT & ANKLE SPECIALIST 2019, VOL. 12 (1) 25-33. DOI: 10.1177/1938640018762474.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515656 MINI MAXLOCK EXTREMEM ISO PLATES AND SCREWS PLATES/SCREWS HRS TORNIER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention