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

Catalog Number	3303-20728M
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/23/2016
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 the lot number has not been identified/confirmed in this case.Since the cage was disposed of by the user, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.In placing the cage, the surgeon reportedly may have been too lateral with his initial approach, and the interbody ended up being anterior of the transverse process instead of being centered in the disc space along the anterior column of the spine.In order to retrieve the interbody and reposition it, the surgeon had to remove the transverse process, which made it difficult to achieve good bone purchase in the corresponding pedicle.The surgeon decided not to reinsert the cage and left the disc space empty.The incident was most likely due to the surgeon's approach/technique.While the implant was not returned, a general review of the manufacturing and inspection records revealed no additional information.User disposed.
Event or Problem Description
On (b)(6) 2017 it was reported to k2m, inc.That a surgery took place in which an cage was unable to be implanted as intended thereby extending the surgery time.Surgery took place (b)(6) 2016.(related to 3004774116-2017-00005).

• Brand Name: ALEUTIAN IBF SYSTEMS
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 6428695
• Report Number: 3004774118-2017-00032
• Device Sequence Number: 18946138
• Product Code: MAX
• UDI-Device Identifier: 10888857072633
• UDI-Public: 10888857072633
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2017

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: 3303-20728M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2017
• Initial Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3303-90151 LOT UNKNOWN; 3303-90381 LOT CJLV004; 6101-2102808TL7-G2 LOT UNKNOWN
• Outcome Attributed to Adverse Event: Other