BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6709787 · Received July 13, 2017

    Report

    Report Number
    1030489-2017-01751
    Event Type
    Injury
    Date Received
    July 13, 2017
    Report Date
    July 11, 2017
    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

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 1606200500, 510K # K131321 AND (B)(4) WAS CLEARED IN THE UNITED STATES. (B)(4). PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: X-RAY REVIEW: POST REVISION X-RAYS FOR T10- ILIUM CONSTRUCT SHOW CORRECTED SAGITTAL BALANCE AND PROPER PLACEMENT OF INSTRUMENTATION. THE OBSERVED BILATERAL ROD FRACTURES ARE LIKELY A RESULT OF THE FAILURE OF FUSION.

    Description of Event or Problem · 1

    LEVELS INVOLVED: T10-S2AI IT WAS REPORTED THAT ON UNKNOWN DATE , POST OP, RODS IN BOTH SIDES WERE BROKEN WHICH LED TO A REVISION OPERATION. THE BROKEN RODS IN BOTH SIDES WERE SWITCHED TO TITANIUM ALLOY 6.0MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490664 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0325770W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention