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

Model Number	7040-100
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	03/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique manual, ifu and fmeas, the most probable root cause is user error; malpositioning of the initial implant and improper implant size selection, using too short of an implant.
Event or Problem Description
The patient had si joint arthrodesis in (b)(6) 2014 where two implants were installed.The patient had a period of pain relief but later reported to a different surgeon with complaints of a recurrence of si joint pain.The surgeon determined that the cranial positioned implant was malpositioned and loose.In (b)(6) 2020, the surgeon performed a revision surgery where he removed the cranial positioned implant and replaced it with a larger implant of the same type.An additional implant was also installed to help fixate the si joint.The patient's joint appears to be better stabilized with less pain.

• 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
• MDR Report Key: 9905463
• Report Number: 3007700286-2020-00031
• Device Sequence Number: 18076149
• Product Code: OUR
• UDI-Device Identifier: 00859256003286
• UDI-Public: 00859256003286
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2020

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 Model Number: 7040-100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 03/31/2020
• 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: 40 YR