MAUDE Adverse Event Report: K2M, Inc. CASCADIA AN Lordotic-Oblique Inserter 10 mm; Intervertebral Fusion Device With Bone Graft, Lumbar

Catalog Number	6101-90167
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A health professional reported that the tip of a cascadia an lordotic-oblique inserter fractured intra-operatively and was difficult to disassemble from an interbody.The procedure was completed successfully with a 15 minute surgical delay.No adverse consequences were reported.Inspection of additional returned products indicates that the tip of a second cascadia lordotic oblique inserter fractured and was difficult to disassemble from an interbody, and that the threading of one cascadia lordotic-oblique interbody was deformed.This report captures the second fractured inserter.

• Brand Name: CASCADIA AN Lordotic-Oblique Inserter 10 mm
• 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: 50182169
• Report Number: 3004774118-2026-00219
• Device Sequence Number: 9860529
• Product Code: MAX
• UDI-Device Identifier: 10888857270107
• UDI-Public: 10888857270107
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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 Catalogue Number: 6101-90167
• Device Lot Number: NDXN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2021
• 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