MAUDE Adverse Event Report: K2M, INC. UNIPLANAR SCREW; SIZE Ø5.5X40 MM; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	2911-35540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that an everest uniplanar screw fractured post-operatively.Revision surgery has not taken place nor been scheduled.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Corrected data: b3.Additional data: d6a.
Additional Manufacturer Narrative
Additional data: a2.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
No new information.

• Brand Name: UNIPLANAR SCREW; SIZE Ø5.5X40 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: 23384322
• Report Number: 3004774118-2025-00161
• Device Sequence Number: 15715064
• Product Code: NKG
• UDI-Device Identifier: 10888857044012
• UDI-Public: (01)10888857044012(11)210521(10)PAXN
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K181603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2911-35540
• Device Lot Number: PAXN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 10/23/2025; 01/26/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/09/2025; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2021
• 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
• Patient Age: 19 YR
• Patient Sex: Female