BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI STRAIGHT ROD (HEX END), 450MM

    MDR report key: 4843887 · Received June 15, 2015

    Report

    Report Number
    1526439-2015-10541
    Event Type
    Injury
    Date Received
    June 15, 2015
    Report Date
    May 18, 2015
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK062174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. SAMPLE NOT AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINT REPORTED BY (B)(4), MEDICAL DIRECTOR: CALL RECEIVED FROM (B)(6). PATIENT HAD CONSISTENT PAIN AFTER SCOLIOSIS SURGERY IN 2011. SURGERY DATE; (B)(6) 2011. DEVICE INVOLVED: 1799-02-525; 1799-02-530, 1799-02-535; 1799-02-545; 1799¿63-450; 1894-03-206. PATIENT WAS FOUND TO BE ALLERGIC TO VANADIUM. (B)(6) WAS CALLING TO OBTAIN GENERAL PATIENT ALLERGIC INFORMATION TO OUR DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387498 TI STRAIGHT ROD (HEX END), 450MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other