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

Catalog Number	6101-90137
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that threading from an aleutian inserter's inner shaft fractured intra-operatively during cage insertion.The threading was left in the implanted cage.The procedure was completed successfully with a 10 minute surgical delay and no adverse consequence to the patient.
Event or Problem Description
It was reported that tip of a cascadia an inserter fractured during use.The tip was left in the implanted cage.The procedure was completed successfully with a 10-minute surgical delay and no adverse consequence to the patient.This report is for the cascadia inserter.

• Brand Name: AN LORDOTIC - OBLIQUE 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 17916877
• Report Number: 3004774118-2023-00125
• Device Sequence Number: 17805656
• Product Code: MAX
• UDI-Device Identifier: 10888857157255
• UDI-Public: 10888857157255
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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: 6101-90137
• Device Lot Number: KJDT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2020
• 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