MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; Ø3.5X24 MM; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	7601-03524-G1
Medical Device Problem Codes	Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised to address a yukon set screw that migrated out of a yukon polyaxial screw post-operatively.This report captures the yukon polyaxial screw.
Event or Problem Description
It was reported that a patient was revised to address a yukon set screw that migrated out of a yukon polyaxial screw post-operatively.This report captures the yukon polyaxial screw.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.Corrected data: g1.
Additional Manufacturer Narrative
H6: coding has been updated to reflect an updated investigation upon receipt of the device.Corrected data: b3.Additional data: d4, d6b, d9, h3, h4.
Event or Problem Description
No new information.

• Brand Name: POLYAXIAL SCREW; Ø3.5X24 MM
• Common Device Name: POSTERIOR CERVICAL 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: 20970091
• Report Number: 3004774118-2024-00146
• Device Sequence Number: 12856799
• Product Code: NKG
• UDI-Device Identifier: 10888857394339
• UDI-Public: (01)10888857394339(11)210426(10)22YT
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2025

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: 7601-03524-G1
• Device Lot Number: 22YT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 03/25/2025; 08/05/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 04/24/2025; 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2021
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 102 KG