MAUDE Adverse Event Report: WARSAW ORTHOPEDIC, INC. ELEVATE¿ Spinal System; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	7770723
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from multiple sources (healthcare provider, distributor) regarding a patient having minimally invasive tran sforaminal lumbar interbody fusion for l3-l4 herniated intervertebral disc (hivd).It was reported that after the cage was implanted and expanded, an x-ray was taken to confirm its position.The imaging revealed that the peek component had separated and broken.The surgeon did the same procedure with the new one, the cage separated and broken too. a new cage of the bigger size was selected and implanted.This replacement expanded successfully without further complications, and the surgery was completed as planned.There were no patient symptoms reported.There were no further complications reported regarding the event.
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.

• Brand Name: ELEVATE¿ Spinal 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 ; +1(763)526-5677
• MDR Report Key: 50912231
• Report Number: 1824199-2026-00099
• Device Sequence Number: 14801162
• Product Code: MAX
• UDI-Device Identifier: 00643169430433
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 7770723
• Device Catalogue Number: 7770723
• Device Lot Number: 1046063W
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 11/22/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female