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

Model Number X079-1255PC-DT

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

The complainant reported on (b)(6) 2019 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.The implants were not loose, and that good fusion had been achieved.The revision procedure occurred on (b)(6) 2019.There were no other patient complications reported.Details involving the original sacroiliac joint fusion system were not available, including the date of surgery, part numbers and lot numbers.In the postoperative management section of the applicable instruction for use (ifu), it states "information on the procedure and patient should be retained to assist in any investigation." it is unknown how many implants were removed during the revision surgery.Visual and functionality assessments could not be performed due to the explanted device(s) 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.If further information is provided by the complainant, follow-up mdr(s) as appropriate, will be submitted.

Event Description

The complainant reported on (b)(6) 2019 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.The implants were not loose, and that good fusion had been achieved.The revision procedure occurred on (b)(6) 2019.There were no other patient complications reported.

Event Description

Additional information was received following submission of 3005031160-2019-00064.The complainant stated that the initial surgery date was (b)(6) 2019.The revision was performed on (b)(6) 2019 because the patient still had pain but responded positively to infiltration.The complainant was able to provide the part number of the device, however, was unable to provide the lot number of the device.Additionally, it was communicated that two devices were explanted during the revision surgery.The following additional mdr is associated with this event.3005031160-2020-00002.

• Brand Name: SILEX SACROILIAC JOINT FUSION SYSTEM
• Type of Device: SILEX SACROILIAC JOINT FUSION SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 9507992
• MDR Text Key: 189069520
• Report Number: 3005031160-2019-00064
• Device Sequence Number: 1
• Product Code: OUR
• Combination Product (y/n): N
• PMA/PMN Number: K140079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: X079-1255PC-DT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 47