MAUDE Adverse Event Report: K2M, INC. AN OBLIQUE INTERBODY; SIZE 10X28X10 MM, 6°; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	6101-2102810NT6-G2
Medical Device Problem Codes	Difficult to Insert (1316); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the insertion of a cascadia oblique interbody as the surgeon attempted to rotate the cage, the tip of a cascadia lordotic - oblique inserter and a thread from the tip of an aleutian inserter inner shaft fractured intra-operatively.The broken pieces were retrieved and x-rays confirmed that there were no artifacts left in patient.The procedure was completed successfully with a 15 minute surgical delay and no adverse consequence to the patient.This report is for the cascadia oblique interbody.
Additional Manufacturer Narrative
H3 other text : device remains implanted.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
It was reported that during the insertion of a cascadia oblique interbody as the surgeon attempted to rotate the cage, the tip of a cascadia lordotic - oblique inserter and a thread from the tip of an aleutian inserter inner shaft fractured intra-operatively.The broken pieces were retrieved and x-rays confirmed that there were no artifacts left in patient.The procedure was completed successfully with a 15 minute surgical delay and no adverse consequence to the patient.This report is for the cascadia oblique interbody.

• Brand Name: AN OBLIQUE INTERBODY; SIZE 10X28X10 MM, 6°
• 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: 18352162
• Report Number: 3004774118-2023-00179
• Device Sequence Number: 15557403
• Product Code: MAX
• UDI-Device Identifier: 10888857281455
• UDI-Public: 10888857281455
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K172009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/10/2024

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: 6101-2102810NT6-G2
• Device Lot Number: NWRV-460403-650496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown