MAUDE Adverse Event Report: K2M, INC. PLATE, 3 LEVEL; SIZE 51 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	AA01-43F51V
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that a patient was revised to address a fractured locking mechanism on an ozark plate and two migrated ozark screws.It was further reported that the patient experienced neck pain.This report captures the plate.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Corrected data: g1 h6 coding has been updated to reflect completion of the investigation.

• Brand Name: PLATE, 3 LEVEL; SIZE 51 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 23644948
• Report Number: 3004774118-2025-00190
• Device Sequence Number: 9829801
• Product Code: KWQ
• UDI-Device Identifier: 10888857401945
• UDI-Public: (01)10888857401945(11)201103(10)NANK
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2026

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: AA01-43F51V
• Device Lot Number: NANK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2020
• 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: Female