MAUDE Adverse Event Report: CARLSMED, INC. APREVO; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	H.L45.02
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device migration can result from several factors, including but not limited to device placement / positioning, patient post-operative compliance, insufficient fixation stability, and variations in individual patient healing responses.Based on the information available, a definitive cause of migration cannot be determined.This report is submitted in accordance with the provisions of 21 cfr part 803.At the time of submission, the information provided may be based on either preliminary findings or a completed investigation, depending on the status of the case.The submission of this report does not constitute an admission by carlsmed, its employees, or the u.S.Food and drug administration (fda) that the device, or carlsmed, caused or contributed to the event described.If relevant new information becomes available, the report will be updated accordingly, as required by regulatory obligations.
Event or Problem Description
Posterior migration of l4/l5 tlif-o aprevo device.Revision surgery performed on (b)(6) 2025.L4/l5 device replaced.

• Brand Name: APREVO
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): CARLSMED, INC.; 1800 aston ave; ste 100; carlsbad CA 92008
• Manufacturer Contact: richard younger ; 1800 aston ave; ste 100; carlsbad, CA 92008
• MDR Report Key: 21882395
• Report Number: 3017936978-2025-00004
• Device Sequence Number: 15613451
• Product Code: MAX
• UDI-Device Identifier: 00810056990824
• UDI-Public: 00810056990824
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2025
• Device Catalogue Number: H.L45.02
• Device Lot Number: 250305.RA.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2025
• 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: 79 YR
• Patient Sex: Female