MAUDE Adverse Event Report: K2M, INC. ALEUTIAN IBF SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	403-22007P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, storage and distribution records according to the description of the product used was conducted.All records revealed that the product lot was manufactured within specifications and distributed in accordance with all operating procedures.A general review of the manufacturing and inspection records did not reveal any contributing information/trends.It is likely that the impact force from the tamp/mallet created a very small crack.The surgeon reportedly felt that the patient's anatomy caused one side of the cage to be forced in a different direction than the other, resulting in the material failure.The surgeon was reportedly comfortable with the stability of the construct and decided to leave the interbody inside the patient.Remains in patient.
Event or Problem Description
It was reported to k2m, inc on (b)(6) 2016 that a cage cracked during insertion and was left in the patient.

• Brand Name: ALEUTIAN IBF SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): K2M, INC.; 751 miller dr se; suite f1; leesburg VA 20175
• MDR Report Key: 5571303
• Report Number: 3004774118-2016-00027
• Device Sequence Number: 517166
• Product Code: ODP
• UDI-Device Identifier: 10888857091832
• UDI-Public: 10888857091832
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K103169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2016

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: Physician
• Device Catalogue Number: 403-22007P
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2016
• Initial Report FDA Received Date: 04/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1