BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON

    MDR report key: 21444180 · Received February 24, 2025

    Report

    Report Number
    1030489-2025-00958
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    January 28, 2025
    Report Date
    September 1, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    LXH
    UDI-DI
    00885074138473
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART# 7485250, LOT# K23B1131 VISUAL INSPECTION CONFIRMED THE PLASTIC CAP OF THE DRIVER HAS BROKEN. OPTICAL INSPECTION DID NOT REVEAL ANY DAMAGE TO THE DRIVER THAT COULD CONTRIBUTE TO THE BREAK. THE DAMAGE IS CONSISTENT WITH 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

    G2: COUNTRY OF ORIGIN IS ARGENTINA. 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 PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING A PROCEDURE BEFORE USING ON PATIENT, A BROKEN SCREWDRIVER WAS IDENTIFIED. THE PROCEDURE INVOLVED THE PATIENT IN VENTRAL RECUMBENCY WITH ASEPTIC TECHNIQUE, MIDLINE INCISION, DISSECTION BY PLANES, HEMOSTASIS, SUBPERIOSTIC DISSECTION FROM T3 TO L3, PLACEMENT OF PEDICULAR SCREWS, AND ADJUSTMENT AND CORRECTION OF KYPHOSIS. RADIOSCOPY VERIFICATION WAS PERFORMED, AND THERE WAS NO ALTERATION OF EVOKED POTENTIAL. THE PROCEDURE ALSO INCLUDED DECORTICATION OF THE SHEET, PLACEMENT OF BONE SUBSTITUTE AND AUTOLOGOUS MATERIAL, DRAINAGE PLACEMENT, AND CLOSURE BY PLANS. THE INSTRUMENT BREAKAGE DID NOT RESULT IN ANY INJURY TO THE PATIENT, DID NOT EXTEND HOSPITALIZATION, AND DID NOT REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT. NO FRAGMENTS OF THE INSTRUMENT REMAINED IN THE PATIENT AND NO FURTHER COMPLICATIONS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT WAS ALREADY USED BEFORE. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE PRE-OP DIAGNOSIS OF PATIENT IS KYPHOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521885 CD HORIZON ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC. 7485250 K23B1131 00885074138473

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female