BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10592003 · Received September 28, 2020

    Report

    Report Number
    1030489-2020-01347
    Event Type
    Malfunction
    Date Received
    September 28, 2020
    Report Date
    September 28, 2020
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    PMA / PMN Number
    K122433
    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 US, HOWEVER A LIKE DEVICE WITH PART#: 55811015550, 510K#: K122433, AND UPN (B)(4) IS APPROVED FOR MARKET IN THE US. 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 PROFESSIONAL VIA A FIELD CONTACT REGARDING A PATIENT WITH A PRE-OPERATIVE DIAGNOSIS OF L2 VERTEBRAL BODY FRACTURE UNDERGOING A REMOVAL PROCESS IN SPINAL THERAPY. IT WAS REPORTED THAT THE LOWER PART OF SCREW HEAD AT LEFT OF L2 BROKE. ON (B)(6) 2019, PPS FIXATION AT 1 ABOVE-1 BELOW WAS PERFORMED. REMOVAL HAD BEEN SCHEDULED TO BE PERFORMED BECAUSE BONE FUSION WAS ACHIEVED. BREAKAGE OF LOWER PART OF SCREW HEAD WAS CONFIRMED DURING X-RAY CHECKING. A FRAGMENT OF THE BROKEN SCREW I.E ONLY THE SCREW UNDER THE DIAMETER 6.5×45 SAS SCREW HEAD REMAINED IN THE PATIENT'S BODY. REMOVAL OF THE BROKEN SCREW WITH THE REMOVAL KIT WAS ALSO CONSIDERED, BUT ACCORDING TO PHYSICIAN 'S JUDGMENT, IT WAS IMPOSSIBLE, SO THE SCREW WAS NOT REMOVED AND WAS CONTINUED BEING PLACED. NO ADDITIONAL PATIENT COMPLICATIONS/SYMPTOMS REPORTED. THE PRODUCT WILL BE RETURNED TO THE PATIENT. LEVELS IMPLANTED: T12 AND L2. DEVICE STATUS REASON: EXPLANTED-PARTIAL ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THAT THE SCREW WAS PREVIOUSLY BROKEN IN THE BODY AND THERE ARE NO PLANS TO REMOVE THE BROKEN FRAGMENT. EVENT DATE: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058223 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC 55711016545 CA18E018

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR