BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYFT PL EXPANDABLE INTERBODY SYSTEM

    MDR report key: 21352935 · Received February 11, 2025

    Report

    Report Number
    1030489-2025-00680
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    January 29, 2025
    Report Date
    May 4, 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
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: PART # 6061002; LOT # K23D1368 VISUAL INSPECTION CONFIRMED THE TIP OF THE CATALYFT INSERTER HAS BROKEN. OPTICAL INSPECTION REVEALED A FLAT FRACTURE SURFACE WITH CIRCULAR MATERIAL FLOW. THE DAMAGE TO THE INSTRUMENT 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

    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 FOR LUMBAR 3-5 SPONDY AND STENOSIS. IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE FOR LUMBAR 3-5 SPONDYLOLISTHESIS AND STENOSIS, SEVERAL ISSUES OCCURRED WITH THE SURGICAL INSTRUMENTS. THE TIP OF THE CATALYFT DRIVER BROKE WHILE EXPANDING THE IMPLANT, AND ALTHOUGH THE TIP WAS RETRIEVED, IT WAS DISCARDED ON THE FIELD AND NOT RECOVERED. ADDITIONALLY, THE NAV TAP COLD WELDED INTO ONE OF THE NAV LOCKS, AND IT WAS DISCOVERED THAT THE TAP ITSELF WAS BENT, ALTHOUGH OTHER INSTRUMENTS WERE ABLE TO BE USED WITH THE NAV LOCK WITHOUT ISSUES. THE TRIM LINE BLADES WERE ALSO DAMAGED, SHOWING SEVERAL MARKINGS AND SCRUFFS FROM HIGH-SPEED BURRS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1625499 CATALYFT PL EXPANDABLE INTERBODY SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MEDTRONIC SOFAMOR DANEK USA, INC 6061002 K23D1368 00763000253554

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Unknown