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

Model Number	6101-90167
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cascadia an inserter and inner shaft broke at the tip intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the inserter.
Event or Problem Description
It was reported that a cascadia an inserter and inner shaft broke at the tip intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the inserter.
Additional Manufacturer Narrative
The device was visually inspected and was observed that the one of the distal tangs were fractured.Material analysis was performed for a similar complaint with the same failure mode, for the same catalog number and found that the tip of the inserter have fractured in a mode of cleavage due to an applied cantilever force.Hardness and elemental constituents were consistent with the print requirements.No material or manufacturing defects were found.Complaint history records were reviewed for this catalog number, no adverse trends were observed.Per the additional information received, the insertion angle was not difficult, the cage was tightly secured in the inserter, and the draw rod did not loosen or move when malleted.The tip fractured immediately when the surgeon began to turn the cage, therefore, application of excessive cantilever force most likely contributed to fracture.

• 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13170602
• Report Number: 3004774118-2022-00002
• Device Sequence Number: 4393050
• Product Code: MAX
• UDI-Device Identifier: 10888857270107
• UDI-Public: 10888857270107
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K160547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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 Model Number: 6101-90167
• Device Catalogue Number: 6101-90167
• Device Lot Number: NBKW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 62 YR
• Patient Sex: Male