MAUDE Adverse Event Report: K2M, Inc. EVEREST MI Polyaxial Screw, Cannulated Size ¿8.5x80 mm; Posterior Cervical Screw System

Catalog Number	M5111-06550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that a patient was revised approximately 10 months post-operatively to address an everest set screw migration and an everest cannulated polyaxial screw fracture.The patient reported experiencing pain.This report captures the screw fracture.

• Brand Name: EVEREST MI Polyaxial Screw, Cannulated Size ¿8.5x80 mm
• Common Device Name: Posterior Cervical Screw System
• 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: 50060267
• Report Number: 3004774118-2026-00214
• Device Sequence Number: 9119400
• Product Code: NKG
• UDI-Device Identifier: 10888857149571
• UDI-Public: 10888857149571
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 09/02/2026

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: M5111-06550
• Device Lot Number: VMBE
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Unknown
• Patient Weight: 156 LB