MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW, CANNULATED; SIZE Ø6.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	M5111-06540-G1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately 15 months post-operatively to address a fractured everest cannulated polyaxial screw.
Additional Manufacturer Narrative
Additional data: a3a, b5.
Event or Problem Description
The patient reported experiencing pain.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional data: b7, d9, h3.H6 coding has been updated to reflect completion of the investigation.

• Brand Name: POLYAXIAL SCREW, CANNULATED; SIZE Ø6.5X40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 21940156
• Report Number: 3004774118-2025-00075
• Device Sequence Number: 13025679
• Product Code: NKB
• UDI-Device Identifier: 10888857380639
• UDI-Public: (01)10888857380639(11)230724(10)UVDA
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K161369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2025

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: M5111-06540-G1
• Device Lot Number: UVDA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 04/29/2025; 07/11/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/15/2025; 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2023
• 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: 48 YR
• Patient Sex: Female