MAUDE Adverse Event Report: K2M, INC. STRAIGHT INSERTER, INNER SHAFT; TLIF II; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	3303-90152
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A health professional reported that the tip of an aleutian tlif ii straight inserter inner shaft fractured off intra-operatively.The procedure was completed successfully with no surgical delay.
Additional Manufacturer Narrative
Additional data: d4, d9, h3, h4.Corrected data: g1.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
No new information.

• Brand Name: STRAIGHT INSERTER, INNER SHAFT; TLIF II
• 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: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 23799737
• Report Number: 3004774118-2025-00211
• Device Sequence Number: 5080404
• Product Code: MAX
• UDI-Device Identifier: 10888857076617
• UDI-Public: (01)10888857076617(11)160208(10)EGHT
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K150481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• 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: 3303-90152
• Device Lot Number: EGHT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/14/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2016
• 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