MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; Ø3.5X16 MM; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	7601-03516
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that a yukon polyaxial screw fractured post-operatively.A revision surgery will be performed.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.

• Brand Name: POLYAXIAL SCREW; Ø3.5X16 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: 21579217
• Report Number: 3004774118-2025-00041
• Device Sequence Number: 18366615
• Product Code: NKG
• UDI-Device Identifier: 10888857349322
• UDI-Public: 10888857349322
• 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
• 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): 05/29/2025

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: 7601-03516
• 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: 02/09/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/29/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown