BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® FENESTRATED SCREW SET

    MDR report key: 21857738 · Received April 17, 2025

    Report

    Report Number
    1030489-2025-01755
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 26, 2025
    Report Date
    May 29, 2025
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KIH
    UDI-DI
    20763000211039
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RADIOGRAPHIC IMAGE REVIEW STATES THAT THE AP X RAY TL FUSION CONSTRUCT CEMENT AUGMENTATION PRESENT AT ALL INSTRUMENTAL LEVELS BILATERALLY. LATERAL X RAY OF IMAGE 1, NO OBVIOUS HARDWARE COMPLICATIONS IDENTIFIED. 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

    H3: 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. 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 L1: BALLOON KYP HOPLASTY, T11-L3: POSTERIOR FIXATION FOR L1 COMPRESSION FRACTURE. IT WAS REPORTED THAT THE CEMENT DELIVERY GUIDE, EQUIPPED WITH A CEMENT DELIVERY TIP, COULD NOT BE FULLY INSERTED. DESPITE THE GUIDE WIRE PASSING THROUGH SMOOTHLY, REPEATED ATTEMPTS FAILED TO ACHIEVE FULL INSERTION. IT WAS INITIALLY DECIDED TO PROCEED, BUT IT WAS DETERMINED THAT CEMENT LEAKAGE WAS INEVITABLE. THE PLAN WAS SHIFTED TO STOP ONCE LEAKAGE OCCURRED. AS EXPECTED, CEMENT BEGAN LEAKING FROM THE SIDE OF THE HEAD DURING FILLING, AND THE PROCESS WAS IMMEDIATELY HALTED. THE LEAKED CEMENT WAS REMOVED, AND IT WAS CONFIRMED THAT THERE WAS SUFFICIENT FREEDOM OF MOVEMENT FOR THE SCREW, RESULTING IN THE DECISION NOT TO REPLACE THE SCREW. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763052 CD HORIZON® FENESTRATED SCREW SET DISPENSER, CEMENT KIH WARSAW ORTHOPEDICS 6550202 H5987759 20763000211039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown