MAUDE Adverse Event Report: K2M, Inc. OZARK View Plate, 2 Level Size 40 mm; Appliance, Fixation, Spinal Intervertebral Body

Catalog Number	AA01-42F40V
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that a patient was revised approximately three months post-operatively to address a fractured and migrated ozark 2 level plate locking cover and four migrated ozark self-tapping variable screws.This report captures the plate.

• Brand Name: OZARK View Plate, 2 Level Size 40 mm
• Common Device Name: Appliance, Fixation, Spinal Intervertebral Body
• 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: 50809816
• Report Number: 3004774118-2026-00241
• Device Sequence Number: 16096078
• Product Code: KWQ
• UDI-Device Identifier: 10888857401594
• UDI-Public: 10888857401594
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• 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
• Report Date (Section B): 09/17/2026

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: AA01-42F40V
• Device Lot Number: 24X4
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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