MAUDE Adverse Event Report: K2M, INC. AN LORDOTIC - OBLIQUE INSERTER; SIZE 10 MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	6101-90167
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tip of a cascadia an lordotic oblique inserter fractured intra-operatively.The procedure was completed successfully with no surgical delay and no adverse consequences to the patient.
Event or Problem Description
A company representative reported that the tip of a cascadia an lordotic oblique inserter fractured intra-operatively.The procedure was completed successfully with no surgical delay and no adverse consequences to the patient.
Additional Manufacturer Narrative
Corrected data: g1 h6 coding has been updated to reflect completion of the investigation.

• Brand Name: AN LORDOTIC - OBLIQUE INSERTER; SIZE 10 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: 20718570
• Report Number: 3004774118-2024-00121
• Device Sequence Number: 12412911
• Product Code: MAX
• UDI-Device Identifier: 10888857270107
• UDI-Public: (01)10888857270107(11)210201(10)NDXN
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 03/24/2025

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: 6101-90167
• Device Lot Number: NDXN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• 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: Female