MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; Ø5.0X26 MM; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	7601-05026
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); Back pain (4895)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately seven months post-operatively to address two fractured yukon polyaxial screws.It was further reported that the fractures were observed on a 6-month post-operative x-ray.A portion of the screws were explanted, however the fractured screw shanks remained in the patient and lower levels were then fused.This report captures the first of two screws.
Event or Problem Description
The patient reported experiencing upper thoracic back pain.
Additional Manufacturer Narrative
Additional information: b5, b7.H6 coding has been updated to reflect completion of the investigation.

• Brand Name: POLYAXIAL SCREW; Ø5.0X26 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 ; 2017608000
• MDR Report Key: 23877175
• Report Number: 3004774118-2025-00229
• Device Sequence Number: 15858664
• Product Code: NKG
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2026

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: 7601-05026
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 07/08/2026
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 130 LB