BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM

    MDR report key: 19113766 · Received April 16, 2024

    Report

    Report Number
    1030489-2024-00273
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 27, 2024
    Report Date
    May 30, 2024
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS PART# 55840026540 ; LOT# H5753753- VISUAL AND OPTICAL EXAMINATION OF MAS BONE SCREW CONFIRMED BREAKAGE OF 3 THREADS FROM THE BASE OF THE BONE SCREW HEAD. NO SURFACE DEFECT IDENTIFIED THAT COULD CONTRIBUTE TO CRACK PROPAGATION. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE REVEALED A FAIRLY BRITTLE FRACTURE WITH SOME INDICATION OF FATIGUE. THE LOWER THREADED PORTION OF THE SCREW APPEARS HAS BEEN DAMAGED FROM THE REMOVAL PROCESS. VISUAL INSPECTION ALSO REVEALED THAT THE TOP PORTION OF THE CROWN OF THE SCREW HAS BEEN WORN FROM THE SEATING OF THE ROD. THE CROWN HAS BEEN PUSHED DOWN THROUGH THE SADDLE OF THE SCREW NOT ALLOWING THE HEAD TO PIVOT ANYMORE. THE BROKEN SCREW APPEARS TO BE DAMAGED FROM OVERLOAD. H6: UPDATED EVAL. CODE METHOD AND EVAL. CODE RESULT POST ANALYSIS 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.

    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. 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 PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH A SCREW IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW BROKE AND WAS EXPLANTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582216 CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MDT SOFAMOR DANEK PUERTO RICO MFG 55840026540 H5753753

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention