BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 18984864 · Received March 27, 2024

    Report

    Report Number
    1030489-2024-00217
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Date of Event
    February 27, 2024
    Report Date
    June 11, 2024
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS PART # 1555106360 LOT # 0925028W VISUAL AND OPTICAL INSPECTION REVEALED THE ROD IS WORN. DAMAGE PRESENT IS CONSISTENT WITH MOVEMENT INSIDE THE BODY FROM NOT BEING PROPERLY FASTENED. ADDITIONAL INFORMATION: H6 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    G4: THIS PART IS NOT APPROVED FOR SALE IN UNITED STATES; HOWEVER, A LIKE DEVICE WITH CATALOG# 1556006300, 510(K)# K121680 AND (B)(4) , IS APPROVED FOR SALE IN UNITED STATES. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAD OLIF (L2/3/4) AND T10~SAI FIXATION AND L5/SPLIF FROM THE REAR. IT WAS REPORTED THAT THE LOOSE SCREW CAUSED INFECTION IN PATIENT. ALTHOUGH FIXATION WAS PERFORMED FROM T10 TO SAI, A WOUND APPEARED ON THE SKIN OF THE RIGHT SAI AREA AND PUS ALSO CAME OUT. WHEN IT WAS DEPLOYED, THE TISSUE FROM THE SKIN SURFACE TO THE SCREW HEAD CONTINUED TO HAVE DARK GRANULATION, AND THERE WAS PUS IN THE SURROUNDING AREA. THE SET SCREW IN THE SCREW HEAD WAS LOOSE ENOUGH THAT IT COULD BE REMOVED WITH FORCEPS, AND THE SURROUNDING TISSUE SHOWED DARK SPOTS AND BLACK POWDERY MATTER. THE SCREW THAT HAD BEEN INSERTED HAD A CLEAR ZONE ON THE IMAGE, BUT IT WAS REASONABLY EFFECTIVE. THE RIGHT SIDE WAS IN A NOTICEABLE CONDITION, BUT WHEN CHECKED THE LEFT SIDE, IT WAS IN THE SAME CONDITION. A REVISION SURGERY WAS PERFORMED DUE TO SUSPICION OF METALLOSIS DUE TO WEAR PARTICLES OF THE IMPLANT, BLACK GRANULATION ON THE SOFT TISSUES, WOUNDS ON THE WOUND SURFACE AND PUS IN THE VICINITY. IMPLANT WAS CUT AND REMOVED. INITIAL SURGERY WAS DONE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED. THE SET SCREWS WERE LOOSE. THERE WERE NO LOOSENESS OR PROBLEM OBSERVED WITH THE SCREW OR PROLOCK LINK. ADDITIONAL INFORMATION RECEIVED. THE ROD INSTALLED IN (PASSED THROUGH) THE BALLAST CLOSED IS 1555106360 (0925028W). THIS TIME, BOTH SET SCREWS WERE LOOSE. THEREFORE, IT IS CONSIDERED THAT THE ROD WENT BACK AND FORTH IN THE HEAD OF THE BALLAST CLOSED, AND WEAR PARTICLES WERE RELEASED. AMONG THE REMOVED AND RECOVERED IMPLANT, THERE WAS A CUT PIECE OF A ROD (1555106360 (0925028W)) THAT WAS HELD IN PLACE TO REMOVE THE BALLAST PLACED IN SAI. IT IS UNCLEAR WHY THE SET SCREW CAME LOOSE. THERE MAY BE EVIDENCE OF METAL SCRAPING DUE TO RUBBING ON THE INSIDE OF THE BALLAST CLOSED HEAD. THERE MAY ALSO BE SIGNS OF SCUFFING ON THE ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441070 CD HORIZON® SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB WARSAW ORTHOPEDICS 1555106360 0925028W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R