MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. SILEX SI JOINT FUSION; SACROILIAC JOINT FIXATION

Model Number	X079-1250PC-DT
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Ambulation or Postural Difficulties (2544)
Date of Event	12/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The company was contacted to obtain the applicable surgical technique guide.He reported that a patient alleged that the physician did not properly seat the implants during the surgical procedure, which left them protruding and severing the left gluteal artery.The artery has been permanently severed, which results in extreme pain when patient attempts to ambulate any distance.The applicable surgical technique guide instructs a posterior lateral approach with the screws traveling posterior to anterior only through a single si joint.It does not mention the great vessels for the associated procedure(s).Access for this system means dissecting the si joint.Depending on how that is achieved, the gluteal artery could be injured, however, the artery is not immediately in the si joint area.The gluteal artery should be far enough anterior that it is not within the required trajectory.A more lateral approach to achieve fixation may have more of a risk of injuring the gluteal artery.
Event or Problem Description
The company was contacted to obtain the applicable surgical technique guide.He reported that a patient alleged that the physician did not properly seat the implants during the surgical procedure which left them protruding and severing the left gluteal artery.The artery has been permanently severed, which results in extreme pain when patient attempts to ambulate any distance.

• Brand Name: SILEX SI JOINT FUSION
• Common Device Name: SACROILIAC JOINT FIXATION
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8127189
• Report Number: 3005031160-2018-00037
• Device Sequence Number: 2324660
• Product Code: OUR
• UDI-Device Identifier: M697X0791250PCDT1
• UDI-Public: M697X0791250PCDT1
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K140079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2018

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: Health Professional
• Device Model Number: X079-1250PC-DT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 12/03/2018
• 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