BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 21032127 · Received December 29, 2024

    Report

    Report Number
    1030489-2024-01786
    Event Type
    Malfunction
    Date Received
    December 29, 2024
    Date of Event
    September 26, 2022
    Report Date
    December 29, 2024
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PLEASE NOTE THAT PRODUCT 1555106100 IS NOT MARKETED IN UNITED STATES, HOWEVER SIMILAR DEVICE WITH PRODUCT ID: 7571050; 510(K): K052747 AND UDI: (B)(4) IS MARKETED IN UNITED STATES. H3: PRODUCT ANALYSIS OF PART # 1555106100; LOT # 0883382W VISUAL AND OPTICAL INSPECTION REVEALED SOME WEAR AND INDENTIONS ON IT FROM THE SEATING AND TIGHTENING OF THE SET SCREW. NO SIGNS OF DAMAGE THAT WOULD HINDER THE ROD FROM FUNCTIONING. THE IMPLANT APPEARS TO FUNCTION AS INTENDED. THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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 HAVING POSTERIOR LUMBAR FUSION FOR LUMBAR DEGENERATIVE SPONDYLOLISTHESIS. IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN BENDING THE ROD, A METAL SOUND THAT WAS NOT NORMALLY HEARD LIKE A BREAKING METAL OCCURRED. JUST IN CASE, IN ORDER TO PREVENT BREAKAGE, A NEW ROD WAS OPENED AND THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS. THE DEFECTIVE ROD DID NOT COME IN CONTACT WITH THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1889765 CD HORIZON® SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB WARSAW ORTHOPEDICS 1555106100 0883382W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown