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

Model Number	X079-1255PC-DT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Following submission of 3005031160-2019-00064, the complainant provided additional information regarding the reportable event, including that two devices were explanted during the revision surgery.This mdr is to account for the second device that was explanted.The initial complaint reported that a patient was scheduled to undergo a revision surgery due to pain from a previous sacroiliac joint fusion procedure.The complainant reported that the original procedure was completed without complication on (b)(6) 2019.The implants were not loose, and good fusion had been achieved.The revision was performed on (b)(6) 2019 because the patient still had pain but responded positively to infiltration.The following mdrs are associated with this event.3005031160-2019-00064; 3005031160-2019-00064-001.A dhr review could not be performed because the complainant was unable to provide lot numbers.Visual and functionality assessments could not be performed due to the explanted devices being discarded at the surgical facility.The ifu potential complications and adverse side effects section lists, "scar formation possibly causing neurological compromise or compression around nerves and/or pain." as a possible complication associated with this procedure.
Event or Problem Description
Following submission of 3005031160-2019-00064, the complainant provided additional information regarding the reportable event, including that two devices were explanted during the revision surgery.This mdr is to account for the second device that was explanted.The initial complaint reported that a patient was scheduled to undergo a revision surgery due to pain from a previous sacroiliac joint fusion procedure.The complainant reported that the original procedure was completed without complication on (b)(6) 2019.The implants were not loose, and good fusion had been achieved.The revision was performed on (b)(6) 2019 because the patient still had pain but responded positively to infiltration.The following mdrs are associated with this event.3005031160-2019-00064; 3005031160-2019-00064-001.

• Brand Name: SILEX SACROILIAC JOINT FUSION SYSTEM
• Common Device Name: SILEX SACROILIAC JOINT FUSION SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 9630067
• Report Number: 3005031160-2020-00002
• Device Sequence Number: 13548096
• Product Code: OUR
• UDI-Device Identifier: M697X0791255PCDT1
• UDI-Public: M697X0791255PCDT1
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2020

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: X079-1255PC-DT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 01/24/2020
• 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
• Patient Age: 52 YR
• Patient Weight: 47