BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYFT¿ PL EXPANDABLE INTERBODY SYSTEM

    MDR report key: 21263625 · Received January 29, 2025

    Report

    Report Number
    1030489-2025-00438
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    August 7, 2023
    Report Date
    January 29, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MAX
    UDI-DI
    00763000253554
    PMA / PMN Number
    K210425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: PART#: 6061002, LOT#: K22K1136, VISUAL EXAMINATION CONFIRMED THE ENTIRE TORX TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USAGE. OPTICAL EXAMINATION OF THE FRACTURE SURFACE REVEALED A FAIRLY FLAT FRACTURE SURFACE AND CIRCULAR MATERIAL DISPLACEMENT. THIS TYPE OF DAMAGE IS CONSISTENT WITH TORSIONAL OVERLOAD. H11: 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 A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A DRIVER USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE DRIVER SHAFT WAS SHEARED OFF. THERE WAS NO PATIENT INVOLVED IN THE EVENT. IT WAS REPORTED THAT THE REPORTED DRIVER WAS USED ON THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511015 CATALYFT¿ PL EXPANDABLE INTERBODY SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MEDTRONIC SOFAMOR DANEK USA, INC 6061002 K22K1136 00763000253554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown