BEUDAMED
    FDA Adverse Event Other Summary report: N

    EDGELOCK PLATING SYSTEM

    MDR report key: 2483751 · Received February 22, 2012

    Report

    Report Number
    3005039508-2012-00002
    Event Type
    Other
    Date Received
    February 22, 2012
    Date of Event
    January 16, 2012
    Report Date
    February 20, 2012
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HRS
    PMA / PMN Number
    K093900
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE MAUDE EVENT REPORT SENT TO US FROM THE FDA, IT IS VERY DIFFICULT TO DETERMINE WHAT EXACTLY FAILED SINCE THE PRODUCT IS NOTED AS ORTHOHELIX TORINER, WHICH ARE TWO SEPARATE COMPANIES. IN ADDITION, THE PT NOTED AN INFECTION AND THE ORTHOHELIX PRODUCT IS SUPPLIED NON-STERILE WITH A LABEL THAT INCLUDE STERILIZATION INSTRUCTIONS. IT IS IMPOSSIBLE TO DETERMINED WHAT CAUSED THE INFECTIONS. ADDITIONALLY, THE PT NOTED A TORN TENDON, WHICH THE ORTHOHELIX PRODUCT IS NOT INTENDED TO TREAT. FINALLY, THE PT STATED THAT SHE BELIEVES THAT THIS PRODUCT WAS REPROCESSED. AGAIN, THE ORTHOHELIX LABEL WARNS NOT TO REUSE IMPLANTS IN PARAGRAPH 5 II.

    Description of Event or Problem · 1

    THE PT FILED MDR STATING ORTHOHELIX TORINER METAL FOOT DEVICE WAS IMPLANTED (B)(6) 2010 AND THAT ANCHORS AND SCREWS LOOSENED AND FAILED. A SERIOUS INFECTIONS LATER DEVELOPED AND THE FOOT NEVER HEALED PROPERLY. THE PT HAS NOW HAD 4 SURGERIES AND IMPLANT WAS PARTIALLY REMOVED (B)(6) 2011 AND STILL HAS PAIN WHEN WALKING. PT FEELS THAT THE PRODUCT WAS REPROCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDGELOCK PLATING SYSTEM BONE FIXATION PLATES AND SCREWS HRS ORTHOHELIX SURGICAL DESIGNS, INC. EDL-001-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention