BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAOSSEOUS FIXATION SYSTEM

    MDR report key: 3108715 · Received May 3, 2013

    Report

    Report Number
    3005039508-2013-00006
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    January 21, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HTY
    PMA / PMN Number
    K120165
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, STATES "... INFECTION, BOTH DEEP AND SUPERFICIAL. ALLERGIES AND OTHER REACTION TO THE DEVICE MATERIAL."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PAIN FOLLOWING SURGERY. THE PATIENT REPORTED PAIN ON (B)(6) 2013. THE PATIENT WAS SEEN ON (B)(6) 2013 AND THE HARDWARE WAS REMOVED. PER THE SURGEON, THE PATIENT WAS TREATED FOR A POST-OPERATIVE INFECTION WITH ANTIBIOTICS (TYPE UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193563 INTRAOSSEOUS FIXATION SYSTEM PIN, FIXATION, SMOOTH HTY ORTHOHELIX SURGICAL DESIGNS, INC. IFS-040-16 2689031

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention