BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 20999106 · Received December 23, 2024

    Report

    Report Number
    1030489-2024-01736
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    December 3, 2024
    Report Date
    February 25, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: PART # 5584111; LOT # K23D1185, VISUAL AND OPTICAL INSPECTION CONFIRMED THE ENTIRE TORX TIP OF INSTRUMENT HAS BEEN SHEARED OFF. OPTICAL INSPECTION REVEALED A FLAT F RACTURE 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 HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE. IT WAS REPORTED THAT TTHE TIP OF THE SCREWDRIVER BROKE OFF WHILE DRIVING A SCREW. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED, AND NO ADDITIONAL TREATMENT OR SURGERY WAS PERFORMED. THE BROKEN INSTRUMENT FRAGMENT WAS NOT LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89109 CD HORIZON SPINAL SYSTEM SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC 5584111 K23D1185

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Unknown