MAUDE Adverse Event Report: K2M, INC. CASCADIA Cervical Interbody 13x16x7 mm, 7°; Intervertebral Fusion Device With Bone Graft, Cervical

Catalog Number	6101-2131607CL7-G2
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	05/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that a patient was revised approximately two weeks post-operatively to address cerebrospinal fluid buildup.It was further reported that a metal fragment was identified posterior to a cascadia cervical interbody during the revision surgery.Preliminary analysis indicates that the metal likely sheared from an ozark variable self-starting screw intra-operatively and that the associated ozark plate or cascadia cervical interbody may have contributed.This report captures the cascadia cervical interbody.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Corrected data: d4.Additional data: d9.

• Brand Name: CASCADIA Cervical Interbody 13x16x7 mm, 7°
• Common Device Name: Intervertebral Fusion Device With Bone Graft, Cervical
• 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: 25480533
• Report Number: 3004774118-2026-00156
• Device Sequence Number: 10448798
• Product Code: MAX
• UDI-Device Identifier: 10888857257719
• UDI-Public: (01)10888857257719(11)251208(17)301207(10)WVPX-001
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6101-2131607CL7-G2
• Device Lot Number: WVPX-001
• 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: 05/23/2026
• Supplement Date Received by Manufacturer: 06/11/2026; 08/27/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 07/06/2026; 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2025
• 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 Sex: Unknown