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

Model Number	SEE SECTION H.10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique manual, ifu, certificates of conformance and fmea, 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 implant in the vicinity of the si joint pain.Additionally, per 300223-k1 (us), si-bone surgical technique manual (c-arm and o-arm): "prior to closure, always obtain final fluoroscopic images in the lateral, inlet, and outlet views to confirm no cortical wall breach, foramen breach, or other malposition.".
Event or Problem Description
The patient had right side si joint arthrodesis in (b)(6) 2019 where three implants were installed.The patient later reported to a different surgeon with complaints of a recurrence of right si joint pain symptoms.Therapeutic injections into the caudal portion of the si joint yielded complete pain relief.Imaging did not show that the caudal positioned implant was loose or malpositioned.The surgeon was not sure if the caudal positioned si joint implant was the pain generator but decided to remove it anyway.In (b)(6) 2020, the surgeon removed the caudal positioned implant using chisels.No other preexisting implants were adjusted or removed.He then added different hardware to the si joint and packed the joint with bone graft.The status of the patient following the revision procedure is not known.
Additional Manufacturer Narrative
Previous revision: in (b)(6) 2020, the surgeon performed a revision procedure where he removed the caudal positioned si joint implant and added different hardware to the si joint.Updated: in (b)(6) 2021, the surgeon removed the remaining cranial and middle positioned implants using chisels as both were solidly fixed in bone and were difficult to remove.The surgeon did not indicate that either of the implants were loose or malpositioned but decided to remove them anyway.The status of the patient following the additional revision procedure is not known.Based on the information provided, review of the surgical technique manual, certificates of analysis, ifu and fmea, there is no indication of device failure and no indication that the devices were out of specification.The most probable root cause could not be determined.It was the surgeon's decision to remove the implants.Additionally, per the surgical technique manual: "prior to closure, always obtain final fluoroscopic images in the lateral, inlet, and outlet views to confirm no cortical wall breach, foramen breach, or other malposition." part number, lot number, manufacturing date, expiration date and udi/gtin number if applicable 1st (superior): ifuse-3d implant, p/n 7065m-90, lot# 2651131, mfd.08/10/18, exp.2023-08-10, gtin 00851085007442 2nd (middle): ifuse-3d implant, p/n 7050m-90, lot# 2651101, mfd.08/09/18, exp.2023-08-09, gtin 00851085007367.
Event or Problem Description
Previous revision: in (b)(6) 2020, the surgeon performed a revision procedure where he removed the caudal positioned si joint implant and added different hardware to the si joint.Updated: in (b)(6) 2021, the surgeon removed the remaining cranial and middle positioned implants using chisels as both were solidly fixed in bone and were difficult to remove.The surgeon did not indicate that either of the implants were loose or malpositioned but decided to remove them anyway.The status of the patient following the additional revision procedure is not known.

• 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
• Manufacturer (Section G): SI-BONE, INC.; 471 el camino real; suite 101; santa clara CA 95050 4482
• Manufacturer Contact: w. reckling, m.d. ; 471 el camino real; suite 101; santa clara, CA 95050-4482 ; 4082070700
• MDR Report Key: 10985834
• Report Number: 3007700286-2020-00128
• Device Sequence Number: 17013837
• Product Code: OUR
• UDI-Device Identifier: 00851085007343
• UDI-Public: 00851085007343
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 11/16/2021

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: 01/29/2024
• Device Model Number: SEE SECTION H.10
• Device Lot Number: SEE SECTION H.10
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male