BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SOLERA FENESTRATED SCREW SPINAL SYSTEM

    MDR report key: 21273232 · Received January 30, 2025

    Report

    Report Number
    1030489-2025-00470
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    February 23, 2023
    Report Date
    January 30, 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
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: COUNTRY OF ORIGIN - GERMANY 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. PRODUCT ANALYSIS: PRODUCT # 55840025550; LOT# H5616222 VISUAL EXAMINATION OF THE MAS BONE SCREWS "TULIP" HAS BEEN SEPARATED FROM THE BONE SCREW AT APPROXIMATELY THE BASE OF THE BONE SCREW HEAD. THE DAMAGE ON THE SPHERE OF THE BONE SCREW APPEARS TO SHOW IT MAY HAVE EXCEEDED THE ACCEPTABLE ANGLE OF THE SCREW. VISUAL AND OPTICAL INSPECTION OF THE "TULIP" IDENTIFY THAT THE C-CLIP HAS BEEN DAMAGED. AFTER VISUAL, OPTICAL, AND MICROSCOPIC EXAMINATION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANTS. THE DAMAGE IS CONSISTENT WITH OVERLOAD. 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(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPINAL DEVICE USED IN PER CUTANEOUS PROCEDURE WITH LONGITUDE. IT WAS REPORTED THAT WHEN INSERTING THE SETSCREW INTO THE TULIP, THE TULIP BROKE INTO TWO PIECES. THERE WERE NO PATIENT SYMPTOMS IN THIS EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. THERE WAS A DELAY OF 50 MINUTES TO REMOVE THE IMPLANT RESIDUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791088 CD HORIZON SOLERA FENESTRATED SCREW SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MDT SOFAMOR DANEK PUERTO RICO MFG 55840025550 H5616222

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown