BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    MDR report key: 20890090 · Received December 10, 2024

    Report

    Report Number
    1030489-2024-01663
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    December 2, 2024
    Report Date
    February 27, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    UDI-DI
    00643169754539
    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

    H3: PRODUCT ANALYSIS #707274470 PART # 6550006 LOT # K24A1163: VISUAL AND OPTICAL INSPECTION CONFIRMED THE BREAK OFF PORTION OF THE SET SCREW IS JAMMED ON THE TIP OF THE DRIVER. THE SET SCREW APPEARS TO BE JAMMED FROM THE BREAK OFF PROCESS. 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

    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 HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SCREW POSTERIOR FIXATION, POSTERIOR LUMBAR FUSION SPINAL THERAPY. IT WAS REPORTED THAT AFTER THE FINAL TIGHTENING OF THE SET SCREW, THE SET SCREW DEBRIS WAS REMOVED FROM THE DRIVER, BUT IT WAS STUCK AND DID NOT COME OFF. INITIAL SURGERY PROCEDURE WAS OBLIQUE LATERAL INTERBODY FUSION SPINAL THERAPY FOR ADJACENT INTERVERTEBRAL DISORDER. LEVELS IMPLANTED WERE L4/5. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE SET SCREW SEEMS IT IS STILL STUCK TO THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678479 CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC 6550006 K24A1163 00643169754539

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown