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

Model Number	7040M-90
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional 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 user error; improper implant size selection, using an implant that was too short.
Event or Problem Description
The patient had left side si joint arthrodesis in (b)(6) 2017 where three implants were placed.The patient later reported a recurrence of pain symptoms.The surgeon determined that the most caudal positioned implant was too short and not fully across the si joint.The surgeon did not indicate that any of the implants were loose.In (b)(6) 2019, the surgeon performed a revision surgery where he removed the most caudal implant.No other implants were adjusted or removed.The status of the patient following the revision procedure is not known.
Event or Problem Description
The patient later requested that the remaining implants be removed.The implants were not malpositioned or loose.The surgeon agreed to remove them at the patient's request.In (b)(6) 2021, the surgeon removed the middle implant using the chisels as it was solidly fixed in bone.The explant void was filled with bone graft.He decided not to remove the remaining superior positioned implant after seeing how difficult it was to remove the middle implant.No new hardware was installed.The patient now has only the initial superior positioned implant remaining in her left si joint.The patient is doing well following the revision procedure.
Additional Manufacturer Narrative
Previous: the patient had one si joint implant removed in (b)(6) 2019 that was too short and not fully across the si joint.Update: the patient later requested that the remaining implants be removed.The implants were not malpositioned or loose.The surgeon agreed to remove them at the patient's request.In (b)(6) 2021, the surgeon removed the middle implant using the chisels as it was solidly fixed in bone.The explant void was filled with bone graft.He decided not to remove the remaining superior positioned implant after seeing how difficult it was to remove the middle implant.No new hardware was installed.The patient now has only the initial superior positioned implant remaining in her left si joint.The patient is doing well following the revision procedure.Based on the information provided, review of the 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 could not be determined.It was the surgeon's decision to remove the implants at the patient's request.

• Brand Name: IFUSE IMPLANT SYSTEM
• Common Device Name: ORTHOPEDIC ROD
• Manufacturer (Section D): SI-BONE, INC.; 471 el camino real; suite 101; santa clara CA 95050 4482
• MDR Report Key: 8495561
• Report Number: 3007700286-2019-00048
• Device Sequence Number: 1650753
• Product Code: OUR
• UDI-Device Identifier: 00859256003262
• UDI-Public: 00859256003262
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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 Expiration Date: 05/02/2022
• Device Model Number: 7040M-90
• Device Lot Number: 2585461
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 03/17/2021
• 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: Other
• Patient Age: 66 YR