BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    MDR report key: 21783116 · Received April 7, 2025

    Report

    Report Number
    1030489-2025-01667
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    December 5, 2022
    Report Date
    April 7, 2025
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    K170679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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 A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING POSTERIOR FIXATION FOR LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT AFTER PLACING THE L3/4/5 OLIF ANTERIOR, POSTERIOR FIXATION WAS PERFORMED ON THE SAME DAY (L3.4.5). THE VOYAGER 55/60 ATMAS WAS IN USE. AFTER THE O-ARM IMAGING, INSERTION WAS INITIATED FROM THE LEFT L3 WITH NAVIGATION (S7). AFTER INSERTING L3 AND 4, AND WHEN INSERTING L5, THE SCREW IS REFLECTED ON THE NAVIGATION SCREEN AND ADVANCES IN AN UNINTENDED DIRECTION BY THE PHYSICIAN. AN ATTEMPT WAS MADE TO REMOVE IT AND INSERT IT IN ANOTHER DIRECTION, BUT IT WAS DIFFICULT. A NAVIGATION PAK NEEDLE WAS USED FROM THIS LOCATION, AND THEN THE VOYAGER 55/60 MAS (HOLLOW SCREW) WAS INSERTED THROUGH THE GUIDEWIRE. THE RIGHT L3 WAS IN USE WITH AN ATMAS, AND THEN THE 5TH AND 4TH ONES WERE INSERTED WITH THE VOYAGER 55/60 MAS (HOLLOW SCREW). THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. THE PATIENT DEVELOPED A POSTOPERATIVE DROP FOOT. CT VERIFICATION SHOWED THAT THERE WAS A HOLE/WAY IN THE LEFT L5 INTERVERTEBRAL FORAMEN WHERE THE SCREW HAD ONCE PASSED AND THAT IT MIGHT BE A HOLE WHEN IT IS INSERTED IN THE UNINTENDED DIRECTION. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574531 CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MDT SOFAMOR DANEK PUERTO RICO MFG 55750046550 H5636517

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown