BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SOLERA 5.5/6.0

    MDR report key: 21236284 · Received January 25, 2025

    Report

    Report Number
    1030489-2025-00337
    Event Type
    Malfunction
    Date Received
    January 25, 2025
    Report Date
    January 25, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    UDI-DI
    00643169043640
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 5584111, SERIAL/LOT #: SW18M010, UDI#: (B)(4); PRODUCT ID: 5584111, SERIAL/LOT #: SW19E016,: , UDI#: (B)(4) ; PRODUCT ID: 5584111, SERIAL/LOT #: SW18G007, UDI#: (B)(4). PRODUCT ID: 5480004V, SERIAL/LOT #: KH16H075, UDI#: (B)(4). PRODUCT ID: 5480004V, SERIAL/LOT #: K22K3144, UDI#: (B)(4) ; PRODUCT ID: 5480004V, SERIAL/LOT #: KH15H056, UDI#: (B)(4). B3: EVENT DATE IS UNKNOWN. H3:PRODUCT ANALYSIS # (B)(4): PART # 5584111, LOT #: SW18M010 VISUAL INSPECTION CONFIRMED THE ENTIRE TORX TIP OF INSTRUMENT HAS BEEN SHEARED OFF AND THE ATTACHMENT PIN TO THE INTERNAL BUSHING HAS BROKEN, CONSISTENT WITH INTERFACE DURING USAGE. OPTICAL EXAMINATION OF THE FRACTURE SURFACE REVEALED A FAIRLY FLAT FRACTURE SURFACE AND CIRCULAR MATERIAL FLOW. THIS TYPE OF DAMAGE IS CONSISTENT WITH TORSIONAL 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 THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A SLEEVE AND T25 BALL ENDED DRIVER USED FOR THE TLIF/THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. EVENT OCCURRED DURING POST-OP. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THE DEVICE WAS NOT FOUND A DEFECTIVE PRODUCT WHEN RECEIVED AT THE FACILITY AND PRODUCT HAS BEEN USED IN ANY OTHER PRIOR PROCEDURE/ SURGERY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2405684 CD HORIZON SOLERA 5.5/6.0 SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC 5584111 SW18M010 00643169043640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown