MAUDE Adverse Event Report: SI-BONE, INC. IFUSE IMPLANT SYSTEM; ORTHOPEDIC ROD

Model Number 7055M-90

Device Problems Failure to Osseointegrate (1863); Loss of Osseointegration (2408)

Patient Problem Arthralgia (2355)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, review of the surgical technique manual, ifu, certificates of analysis and fmeas, there is no indication of device failure and no indication that the device was out of specification.The most probable root cause is pseudoarthrosis and joint diastasis of the si joint.Part numbers, lot numbers, manufacturing dates, expiration dates and udi/gtin numbers: 1st (superior): ifuse implant, p/n 7060-90, lot# 152790, mfd.02/27/2013, exp.2018-02-27, (b)(4).2nd (second): ifuse implant, p/n 7050-90, lot# 222225, mfd.10/20/2014, exp.2019-10-20, (b)(4).

Event Description

The patient had left side si joint arthrodesis in (b)(6) 2015 where three implants were placed.The patient also had three iliosacral screws in the joint.The patient later presented to a new surgeon with complaints of left si joint pain.The surgeon determined pseudoarthrosis and joint diastasis of the left si joint.In (b)(6) 2018, the surgeon removed the most cranial and middle positioned implants, removed the iliosacral screws and decorticated the joint.The surgeon then installed two new ifuse implants in different positions to help stabilize the joint.No other preexisting implants were adjusted or removed.The status of the patient following the revision is not known.

Manufacturer Narrative

Updated: in (b)(6) 2021, the surgeon performed an additional revision procedure where he removed a suspected loose implant.He then installed a new implant of the same type packed with bone graft into the explant void.The status of the patient following the revision procedure is not known.

Event Description

Previous: tthe patient had left side si joint arthrodesis in (b)(6) 2015 where three implants were placed.The patient also had three iliosacral screws in the joint.The patient later presented to a new surgeon with complaints of left si joint pain.The surgeon determined pseudoarthrosis and joint diastasis of the left si joint.In (b)(6) 2018, the surgeon removed the most cranial and middle positioned implants, removed the iliosacral screws and decorticated the joint.The surgeon then installed two new ifuse implants in different positions to help stabilize the joint.No other preexisting implants were adjusted or removed.Updated:the surgeon later determined that the second implant that was added in (b)(6)2018 may have been loose.In (b)(6) 2021, the surgeon performed an additional revision procedure where he removed the suspected loose implant.He then installed a new implant of the same type packed with bone graft into the explant void.The status of the patient following the revision procedure is not known.

• Brand Name: IFUSE IMPLANT SYSTEM
• Type of Device: ORTHOPEDIC ROD
• Manufacturer (Section D): SI-BONE, INC.; 471 el camino real; suite 101; santa clara CA 95050 4482
• MDR Report Key: 7660386
• MDR Text Key: 113090852
• Report Number: 3007700286-2018-00055
• Device Sequence Number: 1
• Product Code: OUR
• Combination Product (y/n): N
• PMA/PMN Number: K190230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2022
• Device Model Number: 7055M-90
• Device Lot Number: 2611581
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 52 YR