BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYFT EXPANDABLE CAGE

    MDR report key: 24615829 · Received March 17, 2026

    Report

    Report Number
    3003120897-2026-00535
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    November 1, 2024
    Report Date
    March 17, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MAX
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    1030489-09/17/2025-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED ARTICLE. D4: MODEL, CATALOGUE NO, LOT ARE UNKNOWN. D 6A: IMPLANT DATE IS UNKNOWN. A2: PLEASE NOTE THAT THE AGE IS BASED OFF AVERAGE AGE OF PATIENT INVOLVED IN THIS EVENT. A 3A: PLEASE NOTE THAT THE GENDER IS BASED OFF AS PER THE MAJORITY OF PATIENTS. G4: PRODUCT INFORMATION IS UNKNOWN. HENCE, 510K IS UNKNOWN ARTICLE REFERENCES - ROHAN JHA, JOSHUA I. CHALIF, SARAH E. BLITZ, ALEXANDER G. YEARLEY, VELINA CHAVARRO, YI LU "IMPROVED CLINICAL AND RADIOGRAPHIC OUTCOMES WITH EXPANDABLE CAGES IN TRANSFORAMINAL LUMBAR INTERBODY FUSION: A PROPENSITY-MATCHED COHORT ANALYSIS", JOURNAL OF NEUROSURGERY: SPINE, VOLUME 42: ISSUE 2, DOI: 10.3171/2024.7. SPINE24215. 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

    LITERATURE WAS REVIEWED REGARDING IMPROVED CLINICAL AND RADIOGRAPHIC OUTCOMES WITH EXPANDABLE CAGES IN TRANSFORAMINAL LUMBAR INTERBODY FUSION: A PROPENSITY-MATCHED COHORT ANALYSIS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: MEDTRONIC CATALYFT EXPANDABLE CAGE AMONG PATIENTS ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE INCLUDED: CSF LEAKAGE, HYPOTENSION, AND CAGE SUBSIDENCE WERE NOTICED FOR PATIENT. SIX PATIENTS WITH EXPANDABLE CAGES WERE REQUIRED A REVISION SURGERY. ADVERSE EVENT REPORTED WERE AS FOLLOWS: ST-ELEVATION MYOCARDIAL INFARCTION, HEMATOMA, FEVER, MOTOR DEFICITS, PERSISTENT BACK PAIN, PERSISTENT LEG PAIN, PERSISTENT LE WEAKNESS, PERSISTENT LE SENSORY DEFICITS/ DISTURBANCES, ADJACENT-SEGMENT DISEASE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681495 CATALYFT EXPANDABLE CAGE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MEDTRONIC SOFAMOR DANEK USA, INC. MSB_UNK_CAGE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention