BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI MAXTORQUE

    MDR report key: 2312996 · Received October 21, 2011

    Report

    Report Number
    2312996
    Event Type
    Injury
    Date Received
    October 21, 2011
    Date of Event
    October 11, 2011
    Report Date
    October 21, 2011
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS HISTORY OF DEGENERATIVE JOINT DISEASE AND PAINFUL BUNION. A FEW MONTHS AGO, PATIENT HAD A SILVER BUNIONECTOMY WITH FIRST METATARSOPHALANGEAL JOINT FUSION, USING ORTHOHELIX PLATE AND SCREW FIXATION. POSTOPERATIVELY, THE PATIENT DEVELOPED EMBOLUS TO THE HALLUX AND THE HALLUX DEVELOPED GANGRENOUS CHANGES. RECENTLY, THE PATIENT RETURNED TO SURGERY FOR AMPUTATION OF THE HALLUX AND REMOVAL OF THE PAINFUL HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI MAXTORQUE CANNULATED SCREW HWC ORTHOHELIX SURGICAL DESIGNS 3.8 30MM *
    2 MAXLOCK EXTREME PLATE UNIVERSAL PLATE HRS ORTHOHELIX SURGICAL DESIGNS MTP-002-SRN *
    3 MODULAR FOOT SYSTEM LOCKING SCREW HWC ORTHOHELIX SURGICAL DESIGNS 3.5 12MM *
    4 MODULAR FOOT SYSTEM NON-LOCKING SCREW HWC ORTHOHELIX SURGICAL DESIGNS 3.5 20MM *
    5 MODULAR FOOT SYSTEM NON-LOCKING SCREW HWC ORTHOHELIX SURGICAL DESIGNS 3.5 16MM *
    6 MODULAR FOOT SYSTEM NON-LOCKING SCREW HWC ORTHOHELIX SURGICAL DESIGNS 4.0 10MM *
    7 MODULAR FOOT SYSTEM LOCKING SCREW HWC ORTHOHELIX SURGICAL DESIGNS 3.5 16MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R NO OTHER THERAPIES