BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SOLERA 5.5/6.0

    MDR report key: 19399473 · Received May 27, 2024

    Report

    Report Number
    1030489-2024-00569
    Event Type
    Malfunction
    Date Received
    May 27, 2024
    Date of Event
    February 26, 2024
    Report Date
    May 27, 2024
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    UDI-DI
    00613994429742
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: PRODUCT ANALYSIS #804314455: PART # 5480004V LOT # K22L3316 VISUAL EXAMINATION CONFIRMED THE INSTRUMENT TIP HAS BROKEN OFF AND NOT RETURNED FOR ANALYSIS. OPTICAL INSPECTION OF THE FRACTURE SURFACE REVEALED A FAIRLY FLAT FRACTURE SURFACE WITH CIRCULAR MATERIAL FLOW. THIS TYPE OF DAMAGE IS CONSISTENT WITH TORSIONAL OVERLOAD. 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 MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS BROKE DURING NORMAL INSTRUMENT SERVICING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329614 CD HORIZON SOLERA 5.5/6.0 SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC 5480004V K22L3316 00613994429742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown