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

Catalog Number	PRO-1076-01
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the proximal knob of a cascadia an lordotic-oblique inserter fractured off intra-operatively, and that it was difficult to disengage a cascadia an lordotic-oblique inserter inner shaft from an implanted cage as a result.The procedure was completed successfully with a 3 minute surgical delay and no adverse consequence to the patient.This report captures the inner shaft.
Event or Problem Description
It was reported that the proximal knob of a cascadia an lordotic-oblique inserter inner shaft fractured off intra-operatively.It was further reported that it was difficult to disengage the inner shaft from an implanted cage as a result.The procedure was completed successfully with a 3 minute surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Corrected data: b5, g1.Additional data: h3.H6 coding has been updated to reflect completion of the investigation.

• Brand Name: AN INSERTER INNER SHAFT
• 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: 20718710
• Report Number: 3004774118-2024-00119
• Device Sequence Number: 12408027
• Product Code: MAX
• UDI-Device Identifier: 10888857525801
• UDI-Public: (01)10888857525801(11)210616(10)PBRE
• 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): 03/20/2025

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: PRO-1076-01
• Device Lot Number: PBRE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• 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