BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SOLERA 5.5/6.0

    MDR report key: 20876899 · Received December 9, 2024

    Report

    Report Number
    1030489-2024-01651
    Event Type
    Malfunction
    Date Received
    December 9, 2024
    Date of Event
    November 12, 2024
    Report Date
    March 8, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    UDI-DI
    00643169043671
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART# 5584109, LOT# K24D1339 VISUAL INSPECTION CONFIRMED THE ENTIRE TORX TIP OF INSTRUMENT HAS BEEN SHEARED OFF. 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. 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 HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER WAS BROKEN WHILE REMOVING THE SCREWS. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS/SYMPTOMS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133555 CD HORIZON SOLERA 5.5/6.0 SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC 5584109 K24D1339 00643169043671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown