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

Model Number	7035M-100
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique manual, ifu 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 implant late loosening possibly due to using an implant that was too small/short.
Event or Problem Description
The patient had right side si joint arthrodesis in (b)(6) 2020 where three implants were installed.Side.The patient had si joint pain relief for approximately six months after the initial procedure before complaining about a recurrence of si joint pain symptoms.The surgeon determined loosening of the caudal positioned implant.In (b)(6) 2021, the surgeon performed a revision surgery where he removed the caudal positioned implant using chisels.He then installed a longer and wider implant of the same type into the explant void.No other preexisting implants were adjusted or removed.The patient's pain symptoms resolved following the revision procedure.

• 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: 11395345
• Report Number: 3007700286-2021-00008
• Device Sequence Number: 16435750
• Product Code: OUR
• UDI-Device Identifier: 00851085007466
• UDI-Public: 00851085007466
• 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: 2020
• 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
• Report Date (Section B): 02/26/2021

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 Model Number: 7035M-100
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 03/01/2021
• 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: 53 YR