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

Model Number	7045-90
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373)
Date of Event	07/15/2016
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 a malpositioned implant not fully crossing the si joint.
Event or Problem Description
In (b)(6) 2015, the patient underwent a right side si joint arthrodesis where three implants were placed.The patient presented to the surgeon a few weeks later with knee complaints that she did not have before.The surgeon determined that one of the implants was not fully across the si joint.In (b)(6) 2016, the surgeon performed a revision surgery where she removed the middle implant that was not fully crossing the si joint and added two additional implants.No other pre-existing implants were adjusted or removed.The status of the patient following the revision is not yet known.
Additional Manufacturer Narrative
The patient had continued pain complaints following the first revision surgery in (b)(6) 2016 and requested that the remaining initial implants be removed.In (b)(6) 2016, a different surgeon performed an additional revision surgery where he removed the two remaining implants from the initial surgery.The implants were removed with considerable effort as they were solidly fixed in bone.The implants that were added during the first revision surgery were not adjusted or removed.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: 5455460
• Report Number: 3007700286-2016-00010
• Device Sequence Number: 895796
• 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: K080398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2016

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: 02/28/2020
• Device Model Number: 7045-90
• Device Lot Number: 333228
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2016
• Supplement Report FDA Received Date: 07/25/2016
• 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: Required Intervention
• Patient Age: 29 YR