BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10383636 · Received August 10, 2020

    Report

    Report Number
    1030489-2020-01053
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 21, 2020
    Report Date
    August 10, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIMILAR DEVICE WITH PRODUCT: 5442022, 510(K): K091974 WAS MARKETED IN US. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE INITIAL REPORTER VIA MEDTRONIC FIELD REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PRE-OPERATIVE DIAGNOSIS OF SCOLIOSIS. IT WAS REPORTED THAT THE BENDER WAS BROKEN WHEN THE CROSSLINK WAS BEING BENT. THERE WERE NO FRAGMENTS LEFT IN PATIENT AND WAS NO DELAY IN SURGERY DUE TO THIS EVENT. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT PERFORMED DUE TO THIS EVENT. THERE WERE NO PATIENT SYMPTOMS REPORTED DUE TO THIS EVENT. THERE WERE NO COMPLICATIONS TO PATIENT/PHYSICIAN WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION RECEIVED ON 05-AUG-2020: IT WAS REPORTED THAT THE CROSSLINK WAS BROKEN, AND THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. THERE WERE NO SYMPTOMS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852056 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS 5432022 0278156W

    Patients

    Seq Age Sex Outcome Treatment
    1