BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5076651 · Received September 15, 2015

    Report

    Report Number
    1030489-2015-02340
    Event Type
    Injury
    Date Received
    September 15, 2015
    Date of Event
    August 1, 2015
    Report Date
    August 26, 2015
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 54840006545, 510K # K091974 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IMPLANT DATE- (B)(6) 2015, REVISION DATE- (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT UNDERWENT TLIF SURGERY AT L3-S1 WITH SPINAL FIXATION SYSTEM.THE PATIENT UNDERWENT REVISION SURGERY BECAUSE TWO S1 SCREWS GOT LOOSENED, THE SURGEON REMOVED THE SCREWS AND THEN INSERTED TWO MAS 7.5MM EACH AT BOTH SIDES OF ILIAC BONE. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610306 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention