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

Model Number	6069076
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having transforaminal lumbar interbody fusion (tlif) spinal therapy for disc herniation.Levels involved was l3-4.It was reported that the cage appeared collapsed and half way out of disc space. there were no further complications or symptoms reported regarding the event.Additional information was received via manufacturer representative that cage backed out, revision surgery with removal of cage was performed with new instrumentation from l2-l5.Disc space was too large to put.
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.
Additional Manufacturer Narrative
Radiographic image review concluded that intra-op lateral image shows interbody graft and inserter was used.Lateral x-ray image l3-4 shows interbody fusion graft appears posteriorly placed and sagittal ct image shows interbody graft subsidence and posterior displacement.Anterior posterior x-ray shows the construct post-op.H3: product analysis of product# 6069073, lot# 1041314w visual examination identified that there was some damage to the implant that appears to be from the removal process.There was also some debris inside of the instrument.Functional examination revealed that the cage was still able to expand and close without any issue.No fault found.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 ORTHOPEDIC, INC.; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDIC, INC.; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 23955297
• Report Number: 1824199-2026-00001
• Device Sequence Number: 5609488
• Product Code: MAX
• UDI-Device Identifier: 00763000246792
• UDI-Public: (01)00763000246792(17)321007(10)1041314W
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K210425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6069076
• Device Catalogue Number: 6069076
• Device Lot Number: 1041314W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female