MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; Ø4.0X34 MM; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	7601-04034
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the neck of a yukon polyaxial screw fractured intra-operatively.The procedure was completed successfully with a 15 minute surgical delay and no adverse consequence to the patient.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Corrected data: g1.H6 coding has been updated to reflect completion of the investigation.

• Brand Name: POLYAXIAL SCREW; Ø4.0X34 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: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 23410214
• Report Number: 3004774118-2025-00162
• Device Sequence Number: 10300370
• Product Code: NKG
• UDI-Device Identifier: 10888857349629
• UDI-Public: 10888857349629
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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: 7601-04034
• Device Lot Number: UNKNOWN
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown