MAUDE Adverse Event Report: K2M, INC. MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE Ø4.0X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	6201-04040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Insufficient Information (4580)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that a patient underwent revision surgery approximately 1 year and 10 months post-operatively to address two fractured mesa polyaxial screws.This report captures the first of two screws.
Event or Problem Description
The patient reported experiencing back pain and discomfort.
Additional Manufacturer Narrative
Additional data: b5, b7, h3.H6.Coding has been updated to reflect completion of the investigation.

• Brand Name: MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE Ø4.0X40 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: 21838702
• Report Number: 3004774118-2025-00062
• Device Sequence Number: 20821839
• Product Code: NKB
• UDI-Device Identifier: 10888857162815
• UDI-Public: (01)10888857162815(11)210121(10)MHEU
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K143334
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: 6201-04040
• Device Lot Number: MHEU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2021
• 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: 17 YR
• Patient Sex: Female