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

Model Number	7045-90
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	10/27/2020
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 is non-union of the si joint, possibly due to insufficient initial fixation.
Event or Problem Description
The patient had right side si joint arthrodesis in (b)(6) 2018 where two implants were installed.The patient later reported to a different surgeon with a recurrence of right side si joint pain symptoms.The surgeon determined non-union of the si joint.The surgeon did not indicate that the implants were loose or malpositioned.In (b)(6) 2020, the surgeon performed a revision procedure where he removed the superior positioned implant using chisels.He then installed a wider implant of the same type in the explant void.He then installed two additional implants of the same type into the right si joint.The preexisting inferior positioned implant was not adjusted or removed.The patient now has four implants in his right si joint.The status of the patient following the 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
• MDR Report Key: 10854399
• Report Number: 3007700286-2020-00107
• Device Sequence Number: 641166
• Product Code: OUR
• UDI-Device Identifier: 00859256003293
• UDI-Public: 00859256003293
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2020

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 Expiration Date: 03/23/2022
• Device Model Number: 7045-90
• Device Lot Number: 493856
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/17/2020
• 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: Other
• Patient Age: 83 YR