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

Model Number	6069076
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a spacer used for l3-5 screws with l4/5 transforaminal lumbar interbody fusion with catalyft cages.It was reported that upon insertion of the cage the surgeon attempted to expand but theexpansion driver did not engage and was freely spinning.Unable to expand, surgeon removed the cage and it was checked for any issues.Using the expansion driver the scrub nurse was able to successfully open and close the cage.The cage was then implanted a second time; and yet again the tip of the driver was unable to engage with the cage.The decision was then made to disengage the cage from the inserter to further troubleshoot.Unfortunately, when later trying to rethread the cage onto the revision sleeve the cage migrated anteriorly and breached the anterior disc space.Due to the dangerous position, one and half hours was lost trying to reverse the cage with various tools as the revision sleeve could not be attached.After the delay, the physician was able to successfully pull the cage back out entirely, tried expanding and collapsing the cage themselves and then were able to rep osition and insert the cage with successful placement and expansion.One month prior the patient already had 1x olif with cage insertion at the level above with 2/3 of anterior longitudinal ligament (all) released and attempted cage insertion at surgical site for the above cage.Cage insertion was aborted due to anterior anatomy.Allograft inserted into disc space at that level.There were no patient symptoms reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
H6: neither the device nor films of applicable imaging studies were 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.

• 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: 25729848
• Report Number: 1824199-2026-00075
• Device Sequence Number: 10554387
• Product Code: MAX
• UDI-Device Identifier: 00763000246792
• UDI-Public: (01)00763000246792(17)330421(10)1064953W
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K210425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2026

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: 6069076
• Device Catalogue Number: 6069076
• Device Lot Number: 1064953W
• 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: 06/17/2026
• Initial Report FDA Received Date: 07/07/2026
• 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
• Patient Sex: Male
• Patient Weight: 80 KG