BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN HIP CONSTRUCT (SHC)

    MDR report key: 5389822 · Received January 25, 2016

    Report

    Report Number
    3034525-2016-00018
    Event Type
    Injury
    Date Received
    January 25, 2016
    Date of Event
    January 4, 2016
    Report Date
    January 24, 2016
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K083582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS PERFORMED FOR THIS DEVICE. THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ROOT CAUSE OF THE FAILURE TO HEAL IS UNDETERMINED. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. A SECOND SURGERY WAS PERFORMED TO REMOVE THE SHC. SIGN FRACTURE CARE INTERNATIONAL CONTINUES TO MONITOR THESE EVENTS AS PART OF OUR POST MARKET ACTIVITIES. THE SURGOEN STATED THAT NO FURTHER TREATMENT IS SCHEDULED AS THE PATIENT HAS BEEN TRANSFERRED TO A DIFFERENT HOSPITAL.

    Description of Event or Problem · 1

    WE BECAME AWARE ON (B)(6) 2016, THAT A SIGN HIP CONSTURCT (SHC) IMPLANTED ON (B)(6) 2012 TO REPAIR A FRACTURE OF THE LEFT HIP, HAD TO BE REMOVED DUE TO PATIENT PAIN AND FAILURE TO HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46715 SIGN HIP CONSTRUCT (SHC) INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| O