BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8130148 · Received December 4, 2018

    Report

    Report Number
    1030489-2018-01601
    Event Type
    Injury
    Date Received
    December 4, 2018
    Date of Event
    October 31, 2018
    Report Date
    December 4, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    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

    THE FOLLOWING ADDITIONAL PRODUCTS WERE ALSO USED IN THE SURGERY. ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. ITEM NO. PRODUCT LOT QUANTITY SIMILAR DEVICE 510K UDI: 10 , GX1014051, 0435581W , 2 , 5441123 , K091974 , (B)(4); 20 , GX1014051, 0435585W , 2 , 5441123 , K091974 , (B)(4); 30 , 7068397 H5326815 4 , 5440130, K102555 , (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE WITH CATALOG # 1474000500, 510K # K091974, UDI# (B)(4) IS APPROVED FOR SALE IN THE US. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INITIAL SURGERY: MAS ON T2/3, HOOK ON L2/3 PRE-OPERATIVE DIAGNOSIS: SCOLIOSIS IT WAS REPORTED THAT POST-OP, THE ROD WAS RAISED DUE TO KYPHOSIS UNDER THE SKIN BETWEEN THE SUPERIOR ANCHOR AND THE INLINE CONNECTOR. INFECTION OCCURRED DUE TO DECUBITUS TO THE PATIENT AT THE BACK PART OF THE ROD. REVISION SURGERY WAS PERFORMED TO REMOVE THE IMPLANTS. THE OPERATION TIME WAS EXTENDED FOR ABOUT 15 MINUTES BECAUSE IT WAS DIFFICULT TO REMOVE THE IMPLANTS. NO FRAGMENT REMAINS IN THE PATIENT. THE PATIENT ISSUE HAS NOT BEEN RESOLVED. NO MALFUNCTION IN ANY PRODUCTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970266 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0289966W

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other| R