BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 20770075 · Received November 25, 2024

    Report

    Report Number
    1030489-2024-01557
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    October 30, 2024
    Report Date
    November 25, 2024
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H11
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PLEASE NOTE THAT THE INVOLVED DEVICE IS NOT MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES MARKETED DEVICE PRODUCT ID#1554006040; UDI# (B)(4); 510K# K122862 H6: 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. 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 UNDERGOING POSTERIOR FIXATION FOR ROD FRACTURE AND RE-ANCHORING. LEVELS IMPLANTED AT TH11-S2AI. IT WAS REPORTED THAT AFTER FINAL FASTENING, WHEN ATTEMPTING TO REMOVE THE PRODUCT, IT COULD NOT BE DETACHED FROM THE SCREW HEAD DESPITE THE LOCK BEING RELEASED. IT IS BELIEVED THAT THE ADJACENT EXTENDER BODY INTERFERED, LEAVING NO SPACE TO MOVE THE EXTENDER EVEN WITH THE LOCK RELEASED, CAUSING IT TO GET STUCK AND NOT DETACH. A PART OF THE TIP WAS DAMAGED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT POST-OPERATIVE INFECTION WAS CONFIRMED AFTER THE INITIAL SURGERY AND CLEANING WAS PERFORMED. THE DATE OF ONSET IS UNKNOWN; NO IMPLANT MALFUNCTIONS WERE CONFIRMED AT THIS TIME. AFTERWARDS, LEFT ROD FRACTURE, LOOSE SET SCREWS IN THE RIGHT SACRAL ILIAC, AND BACKOUT OF THE L5/S CAGE WERE CONFIRMED, AND REPEAT SURGERY WAS PERFORMED ON OCTOBER 30, 2024. NO PATIENT SYMPTOMS ARE ASSOCIATED WITH THE MALFUNCTION. SCREW WAS ADDED FOR POSTOPERATIVE INFECTIONS. NO DEFECTS IN THE IMPLANT ITSELF ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE IS NO CAUSAL RELATIONSHIP BETWEEN POST-OPERATIVE INFECTION AND ROD, SET SCREW AND CAGE DUE TO IMPLANT. CAGE BACKOUT, ROD FRACTURE AND SET SCREWS DID NOT CAUSE ANY NEUROLOGICAL SYMPTOMS. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE IS NO MALFUNCTION RELATED TO EXTENDER IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014890 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS 1554106500 0916487W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention