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

Model Number	7035-90
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/21/2016
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 fmea, there is no indication of device failure and no indication that the device was out of specification.The most probable root cause is improper implant size selection.
Event or Problem Description
In (b)(6) 2016, the patient underwent right side si joint arthrodesis where three implants were placed.A follow-up ct scan the following day revealed than an implant had not fully crossed the si joint into the sacrum.The patient did not have any pain complaints.The surgeon performed a revision surgery a few days later where he advanced the second implant further across the si joint into the sacrum for a better long term outcome.The status of the patient following the revision surgery is not yet known.

• Brand Name: IFUSE IMPLANT SYSTEM
• Common Device Name: ORTHOPEDIC ROD
• Manufacturer (Section D): SI-BONE, INC.; 3055 olin avenue; suite 2200; san jose CA 95128 2066
• MDR Report Key: 5401718
• Report Number: 3007700286-2016-00006
• Device Sequence Number: 471125
• Product Code: OUR
• UDI-Device Identifier: 00859256003279
• UDI-Public: 00859256003279
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Report Date (Section B): 01/28/2016

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: 11/30/2018
• Device Model Number: 7035-90
• Device Lot Number: 166193
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2016
• 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: 43 YR