BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9160089 · Received October 5, 2019

    Report

    Report Number
    1030489-2019-01123
    Event Type
    Malfunction
    Date Received
    October 5, 2019
    Report Date
    October 5, 2019
    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

    OTHER: PAIN, NON-UNION. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG #: 5440030, 510K #: K102555 AND UDI #: (B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT FIXATION AT L2-L5 DUE TO SPINAL CANAL STENOSIS. ON AN UNKNOWN DATE, POST-OP, THE SET SCREW ON THE RIGHT OF L5 BACKED OUT. THE PATIENT DID NOT ACHIEVE SOLID FUSION. THE PATIENT ALSO EXPERIENCED RIGHT LOWER LIMB PAIN. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH THE SET SCREW WAS RETRIEVED AND RE-FIXATION AND BONE GRAFTING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954193 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA H11F5614

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R