MAUDE Adverse Event Report: K2M, INC. ALEUTIAN TLIF II Adjustable Inserter; Intervertebral Fusion Device With Bone Graft, Lumbar

Catalog Number	3303-90603
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction

• Brand Name: ALEUTIAN TLIF II Adjustable Inserter
• Common Device Name: Intervertebral Fusion Device With Bone Graft, Lumbar
• Manufacturer (Section D): K2M, INC.; 600 hope pkwy; leesburg VA 20175
• Manufacturer (Section G): K2M, Inc.; 600 hope pkwy se; leesburg VA 20175
• Manufacturer Contact: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; +1(201)760-8000
• MDR Report Key: 25820822
• Report Number: 3004774118-2026-00204
• Device Sequence Number: 10383570
• Product Code: MAX
• UDI-Device Identifier: 10888857157668
• UDI-Public: (01)10888857157668(11)250509(10)XTUC
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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 Catalogue Number: 3303-90603
• Device Lot Number: XTUC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 07/14/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown