BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CORTEX SCREW SELF-TAPPING 40MM

    MDR report key: 3243550 · Received July 23, 2013

    Report

    Report Number
    2520274-2013-04617
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 28, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    PMA / PMN Number
    K974537
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE IS FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL INFORMATION: ADDED SMOKER.

    Description of Event or Problem · 1

    THE PATIENT HAD A FALL FROM A LADDER AND UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) FOR LEFT INTERTROCHANTERIC HIP FRACTURE, REPAIRED ON (B)(6) 2012. PATIENT HAD A REACTION/RASH AFTER A FEW DAYS. THE ANESTHETIST NOTED THE POSSIBILITY OF BED BUG INFESTATION DUE TO THE TRIAD OF LESIONS NOTED ON THE PATIENTS ARM. HE RECEIVED BENADRYL WITHIN THE FIRST FOUR DAYS OF THE PROCEDURE. ON (B)(6) 2013, THE HARDWARE WAS PARTIALLY REMOVED DUE TO PATIENT PAIN AT THE SKIN SURFACE. THIS IS REPORT 6 OF 8 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THE PATIENT IS STILL EXPERIENCING PAIN AND WILL DISCUSS WITH HIS SURGEON THE POSSIBLE FULL REMOVAL OF HARDWARE. THIS IS REPORT 6 OF 8 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342601 4.5MM CORTEX SCREW SELF-TAPPING 40MM KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention