BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM

    MDR report key: 21759307 · Received April 2, 2025

    Report

    Report Number
    1030489-2025-01604
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    June 27, 2024
    Report Date
    April 3, 2025
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG# 55840025550T, 510K# K152604 AND UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. RADIOGRAPHIC IMAGE REVIEW RESULTS- LATERAL FLUORO SHOWS SCREWS INSERTED BILATERALLY AT L5 S1. NO OBVIOUS HARDWARE COMPLICATION SEEN. 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 THE PROCEDURE WAS L5-S1, OSTEOPOROTIC BONE. IT WAS REPORTED THAT THE SURGEON ASKED FOR A 7.5X40MM SOLERA FNS SCREW FROM THE LOANER SET. IT ONLY CONTAINS 7.5X45MM SCREWS AS THE SHORTEST 7.5MM SCREW. THE LOANER CONTAINS TOO LONG 7.5MM SCREWS WITH RISK OF PENETRATING THE FURTHER CORTEX OF THE VERTEBRA RESULTING THE RISK OF HAVING CEMENT LEAKING OUT IN THE CANAL. TOOK A NORMAL SOLERA MAS 7.5X45 AND USED IT BICORTICALLY IN PURPOSE TO GET BETTER GRIP AS THE MOST OPTIMAL SCREW WOULD HAVE BEEN A 7.5X40MM SOLERA FNS WITH CEMENT. NO ONE GOT HURT OR HARMED BUT THE SURGEON WANTED TO REPORT THAT THE TRAY ISN'T OPTIMALLY CONSTRUCTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1957099 CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MDT SOFAMOR DANEK PUERTO RICO MFG 55040027545 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male