BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL HUMERAL NAIL, CANNULATED, LEFT T2 PROX. HUM. Ø8 X 150 MM

    MDR report key: 6114761 · Received November 18, 2016

    Report

    Report Number
    0009610622-2016-00512
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 24, 2016
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K042396
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED AND THEREFORE WILL NOT BE RETURNED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THE REP THAT UPON FOLLOW UP X-RAY DURING FRACTURE CLINIC THE CONSULTANT HAS NOTICED THAT SCREWS BACKED-OUT OF THE NAIL CAUSING THE FIXATION TO FAIL. DATE OF SURGERY: (B)(6) 2016. DATE THAT THIS WAS NOTICED: FRACTURE CLINIC (B)(6) 2016. NO ADVERSE EVENTS DURING INITIAL SURGERY. PATIENT IS (B)(6). SHE HAS NOT FALLEN OR USED THE ARM OTHER THAN WITH PENDULA EXERCISES FOR 2-3 WEEKS. THREE 5MM LOCKING SCREWS BACKED OUT. THE PATIENT IS CONSIDERING REVISION TO REVERSE SHOULDER REPLACEMENT. IF LEFT ALONE I THINK HER FUNCTION WILL BE VERY POOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764641 PROXIMAL HUMERAL NAIL, CANNULATED, LEFT T2 PROX. HUM. Ø8 X 150 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention