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

Model Number	6068093
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Neuralgia (4413)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
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 healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy.It was reported that, catalyft pl 9mm short was implanted during a case on (b)(6) 2025 expansion was performed using a "two finger" technique to minimize subsidence forces.Implantation was unremarkable and done according to surgical technique.Physician notified rep on (b)(6) 2025 about revision surgery on this patient to revise catalyft cage, which had retropulsed and it was impinging in spinal canal.Review of imaging showed that the cage was not positioned as anteriorly as it should have been.It also appears that the cage did not collapse in-situ.Procedure performed was right sided transforaminal lumbar interbody fusion.Retropulsed cage was removed and a short 9mm pl40 was put in its place.Patient suffered left sided leg pain as a result.There were no further complications reported regarding the event.
Event or Problem Description
Additional information received from manufacturer representative stating pain was resolved.No further complications reported.
Additional Manufacturer Narrative
H3: product analysis of part # 6068093; lot # 1064202w, visual and macroscopic inspection confirmed the cage has a lot of debris and is jammed because of the debris.Functional inspection could not be performed because of all the debris.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: 23484415
• Report Number: 1824199-2025-00072
• Device Sequence Number: 21391747
• Product Code: MAX
• UDI-Device Identifier: 00763000246723
• UDI-Public: (01)00763000246723(17)330421(10)1064202W
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K210425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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: 6068093
• Device Catalogue Number: 6068093
• Device Lot Number: 1064202W
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female