MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CATALYFT¿ PL EXPANDABLE INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	6068073
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from the health care provider via a manufacturer representative regarding a device used for spinal therapy.It was reported that the catalyst implant was introduced a few months ago (b)(6) 2024) and the revision showed that the cage has collapsed and the expansion is not the same as when it was inserted during surgery.The initial height has not been maintained and this has caused problems in the patient's lordosis and discomfort after implantation.There were no further complications reported regarding the event.Additional information received from manufacturer representative that there is no plan/schedule for the revision surgery.
Additional Manufacturer Narrative
G2 - the country of the event is spain h6 - the device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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
Radiographic image review performed by dr hoit and the review comments are as per below 1.Magnified lateral xray l5 s1 tlif 2.Magnified lateral xray l5 s1 tlif cage is collapsed in image 1 compared to image 2.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.

• Brand Name: CATALYFT¿ PL EXPANDABLE INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21603796
• Report Number: 1030489-2025-01362
• Device Sequence Number: 21124614
• Product Code: MAX
• UDI-Device Identifier: 00763000246693
• UDI-Public: 00763000246693
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K210425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6068073
• Device Catalogue Number: 6068073
• Device Lot Number: 1021729W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 03/28/2025
• Date Device Manufactured: 05/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male