BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH 3DX

    MDR report key: 21390214 · Received February 15, 2025

    Report

    Report Number
    1030489-2025-00800
    Event Type
    Malfunction
    Date Received
    February 15, 2025
    Date of Event
    August 1, 2023
    Report Date
    February 15, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    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 OF PART # 8350393 ; LOT # EM14K006 VISUAL EXAMINATION CONFIRMED APPROXIMATELY 4MM OF THE INSTRUMENT TIP HAS BEEN BROKEN OFF AND NOT RETURNED FOR ANALYSIS. OPTICAL INSPECTION OF THE FRACTURE SURFACE REVEALED A FAIRLY FLAT FRACTURE WITH CIRCULAR MATERIAL FLOW. THIS TYPE OF DAMAGE IS CONSISTENT WITH TORSIONAL OVERLOAD. THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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 REVISION SURGERY FOR ADJACENT SEGMENT DISEASE. IT WAS REPORTED THAT THE SCREWDRIVER BROKE WHEN INSERTING AN ADDITIONAL L4 RIGHT SCREW. THE BROKEN PIECE FITS FLUSH WITH THE SCREW, SO THE PHYSICIAN DECIDED TO PLACE IT IN THE BODY. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151110 TSRH 3DX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC 8350393 EM14K006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown