MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW ML; Ø5.0X28 MM; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	7601-05028M-G1
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 tulip of a yukon polyaxial screw fractured off intra-operatively and it is unknown if a fractured component remains in the patient.The procedure was completed with a 60 minute surgical delay.
Additional Manufacturer Narrative
Corrected data: g1.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
No new information.

• Brand Name: POLYAXIAL SCREW ML; Ø5.0X28 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: 23410274
• Report Number: 3004774118-2025-00163
• Device Sequence Number: 18399144
• Product Code: NKG
• UDI-Device Identifier: 10888857395824
• UDI-Public: 10888857395824
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• 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): 02/17/2026

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: 7601-05028M-G1
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 01/25/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 02/17/2026
• 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