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

Catalog Number	603-20728C
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.A general review of the manufacturing and inspection records did not reveal any contributing information/trends.The product was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as no lot number has been identified/confirmed in this case.Since the interbody remains in the patient no physical, material, chemical evaluation could be performed.It was alleged that a small piece of the implant broke off during the use of a pusher/mallet.Therefore, it is likely that the impact force from the mallet created a very small crack, which then propagated after repetitive hits with the mallet, resulting in a material failure.The interbody was left in the patient, and the case was reportedly completed successfully.Remains in patient.
Event or Problem Description
It was reported to k2m inc on (b)(6) 2016 that a small piece of an interbody fractured off during implant insertion/impaction.

• 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: 5534873
• Report Number: 3004774118-2016-00023
• Device Sequence Number: 973067
• Product Code: MAX
• UDI-Device Identifier: 10888857121645
• UDI-Public: 10888857121645
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K110843
• 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): 03/10/2016

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: 603-20728C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2016
• Initial Report FDA Received Date: 03/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1