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

Catalog Number	3303-21028M
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	12/02/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.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.If more information becomes available manufacturer will file a follow-up report at that time.
Event or Problem Description
It was reported to k2m, inc.On (b)(6) 2015 that a revision surgery took place in which a tlif ii cage was removed.The patient reportedly had signs of infection at the surgical site approximately 2 days post-op.Revision surgery took place (b)(6) 2015.
Additional Manufacturer Narrative
Previous testing was performed to ensure the materials used in k2m's implants are biocompatible and do not pose additional risk to the patient.We concluded in those tests that the materials used for our implants are all commonly used in the medical device industry.The materials used by k2m have been successfully evaluated for biocompatibility per iso 10993, biological evaluation of medical devices, the harmonized standard used by the industry.Furthermore, all of our tlif implants are manufactured from an implantable grade plastic material that has an approved fda master file.The cleaning and sterilization history of the subject device performed by the user facility is unknown.

• 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: 5366530
• Report Number: 3004774118-2015-00063
• Device Sequence Number: 13483794
• Product Code: MAX
• UDI-Device Identifier: 10888857073357
• UDI-Public: 10888857073357
• 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: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Followup
• Report Date (Section B): 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Catalogue Number: 3303-21028M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2016
• Supplement Report FDA Received Date: 02/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention