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

Model Number	7060-90
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	11/26/2018
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 implant loosening.
Event or Problem Description
The patient had right side si joint arthrodesis in (b)(6) 2016 where two implants were placed.The patient did well for several months following the initial procedure but later complained of a recurrence of back pain symptoms.The surgeon determined that the cranial positioned implant may have been loose.In (b)(6) 2018, the surgeon performed a revision surgery where he removed the cranial positioned implant using chisels and replaced it with a wider implant of the same type.The surgeon did not adjust or remove the second preexisting implant.He then added an additional implant between the two existing implants.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: 8184843
• Report Number: 3007700286-2018-00110
• Device Sequence Number: 2025026
• Product Code: OUR
• UDI-Device Identifier: 00859256003323
• UDI-Public: 00859256003323
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2018

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: 07/23/2023
• Device Model Number: 7060-90
• Device Lot Number: 493355
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/20/2018
• 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: 71 YR