MAUDE Adverse Event Report: K2M, INC. AN INSERTER; SIZE 8.5 MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	602-90776
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tip of an aleutian an inserter fractured and the tip of an aleutian an inserter inner shaft deformed intra-operatively.The procedure was completed successfully with a five minute surgical delay and no adverse consequence to the patient.This report captures the aleutian an inserter.
Event or Problem Description
A company representative reported that the tip of an aleutian an inserter had fractured.Upon inspection of the returned device it was observed that the tip had fractured and deformed.
Additional Manufacturer Narrative
Additional data: b5, d4, d9, h3, h4.H6 coding has been updated to reflect investigation conclusion.

• Brand Name: AN INSERTER; SIZE 8.5 MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 22777807
• Report Number: 3004774118-2025-00127
• Device Sequence Number: 21154476
• Product Code: MAX
• UDI-Device Identifier: 10888857120471
• UDI-Public: (01)10888857120471(11)210129(10)NEJU
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160547
• 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): 12/10/2025

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: 602-90776
• Device Lot Number: NEJU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown