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

Model Number	6069096
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Back pain (4895)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G2: country of event - germany.Bfarm regulatory body reference # (b)(4).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 healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy.It was reported that, on (b)(6) 2024 the cage had distraction loss from 15.1 to 14mm, increasing cage sintering lumbar spine 2.3 lordosis idem.Distraction failure of the intervertebral cage, height loss within 2 months after surgery (dorsoventral spondylodesis lv3-4).As a result, screw loosening of the screw-rod system in dorsal spondylodesis lv3/4 and lack of bony fusion in the treated segment.The screw implantation was inconspicuous.The operation took place on (b)(6) 2024.The x-ray control on (b)(6) 2024 showed loss of distraction of the cage and sintering in the vertebral bodies lumbar spine 2 and 3 both in antero-posterior and sagittal sequence.No revision is in plan to explant the cage.Procedure/technique performed was transforaminal lumbar interbody fusion.There were no patient symptoms reported.No further complications reported regarding the event.
Additional Manufacturer Narrative
Radiographic image review states, antero-posterior x-ray images of 2 panels.Images show l2-5 interbody fusion.There is a collapse of interbody graft in right panel appeared to left image.Lateral view of images shows height loss of interbody graft.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
Additional information received states, patient had post operative back pain.No further complications reported.
Additional Manufacturer Narrative
Additional information: b5, h6.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: 21280544
• Report Number: 1030489-2025-00477
• Device Sequence Number: 9530280
• Product Code: MAX
• UDI-Device Identifier: 00763000246822
• UDI-Public: 00763000246822
• 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,Followup
• Report Date (Section B): 03/10/2025

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: 6069096
• Device Catalogue Number: 6069096
• Device Lot Number: 0986514W
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 02/12/2025; 02/12/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/04/2025; 03/10/2025
• Date Device Manufactured: 10/04/2023
• 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: 82 YR
• Patient Sex: Male