BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10917067 · Received November 30, 2020

    Report

    Report Number
    1030489-2020-01707
    Event Type
    Malfunction
    Date Received
    November 30, 2020
    Report Date
    November 30, 2020
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS NOT MARKETED IN US. 510(K) FOR SIMILAR PRODUCT WITH CATALOGUE # 1476200500 IS K132111. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF PRESSURE ULCER FORMATION ON THE SKIN AND METAL ALLERGY. IT WAS A REVISION SURGERY. IT WAS REPORTED THAT THERE WAS ROD BREAKAGE. SUBCUTANEOUS PRESSURE ULCER WAS FORMED, IT WAS UNKNOWN WHETHER IT WAS CAUSED BY ROD BREAKAGE. ADDITIONAL SURGERY OF REMOVING ALL PERFORMED AS A RESULT OF THIS EVENT. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. THERE WERE NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. THE FIRST IMPLANT WAS ON (B)(6) 2011, THE SECOND IMPLANT WAS ON (B)(6) 2012. THE ORIGINAL MAIN COMPLAINT, VERTEBRAL BODY FRACTURE, WAS CURED AND THE PAIN WAS RELIEVED, AND THERE WAS NO WORSENING OF SYMPTOMS DUE TO ROD BREAKAGE. THE PRESSURE ULCER THAT HAD FORMED AROUND THE CROSSLINK THAT HAD ENTERED THE THORACIC WAS PARTIALLY EXCISED AND SUTURED, AND THE FRACTURED PART WAS NOT THE CAUSE OF THE PRESSURE ULCER BECAUSE THE TREATMENT WAS PERFORMED AT A DISTANCE FROM THE FRACTURED PART ACCORDING TO THE OPERATING SURGEON OPINION. BEDSORE WAS REPORTED AROUND WHERE X10 CROSSLINK WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381915 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS 1476100500 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention