MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW, CLOSED; SIZE Ø8.5X90 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	2901-08590G
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that a patient underwent revision surgery to address two everest polyaxial screw tulip disengagements.This report captures the second of two screws.
Additional Manufacturer Narrative
Additional data: b5, h3.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
It was further reported that the patient fell and experienced pain.

• Brand Name: POLYAXIAL SCREW, CLOSED; SIZE Ø8.5X90 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: 23439760
• Report Number: 3004774118-2025-00167
• Device Sequence Number: 4758640
• Product Code: NKB
• UDI-Device Identifier: 10888857037700
• UDI-Public: (01)10888857037700(11)250210(10)WGVT
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140529
• 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): 12/20/2025

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: 2901-08590G
• Device Lot Number: WGVT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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: Unknown