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

Model Number	6069073
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Back pain (4895)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Information was received from the health care professional via a manufacturer representative regarding a device used for transforaminal lumbar interbody fusion therapy.It was reported that the cage has lost distraction height from 12 to 11mm, lordosis loss 14.6 to 12.1° implanted at the level l4/l5.Patient had post operative back pain.No additional treatment or surgery performed as a result.No further complications reported regarding the event.
Additional Manufacturer Narrative
Radiographic image review states, the lateral x ray of two panel image was provided.L4-5 interbody graft collapsed, subsidence was seen in right panel compared to left.Ap x ray of 2 panels show l4-5 interbody graft collapsed in right panel compared to left.The notified date of this event is corrected to 2025-01-20.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: 21581199
• Report Number: 1030489-2025-01297
• Device Sequence Number: 8895745
• Product Code: MAX
• UDI-Device Identifier: 00763000246785
• UDI-Public: 00763000246785
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K210425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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: 6069073
• Device Catalogue Number: 6069073
• Device Lot Number: 0978663W
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/11/2025
• Date Device Manufactured: 08/27/2023
• 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 Age: 84 YR
• Patient Sex: Female