BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 11670118 · Received April 15, 2021

    Report

    Report Number
    1030489-2021-00496
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 27, 2021
    Report Date
    April 15, 2021
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A SIMILAR DEVICE WITH PRODUCT ID 1474000500 AND 510K # K091974 WAS MARKETED 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

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH REVISION SURGERY. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE SCOLIOSIS. IT WAS REPORTED THAT THE LEFT ROD WAS BROKEN. ROD REPLACEMENT AND EXTENSION. THE CROSSLINK HAD ALSO BEEN REPLACED. REPLACEMENT DUE TO ROD BREAKAGE. THE PATIENT ISSUE HAS BEEN RESOLVED. THE ROD HAD BEEN INSERTED ON (B)(6) 2019. IT WAS A GROWING ROD TREATMENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568699 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS 1476300500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention