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

Model Number	7050-90
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This previously unreported revision was discovered in an unrelated analysis of records.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 user error; improper implant size selection, using an implant that was too long.
Event or Problem Description
This previously unreported revision was discovered in an unrelated analysis of records.The patient had right side si joint arthrodesis in (b)(6) 2016 where three implants were placed.It is not known if the patient had any pain complaints.In (b)(6) 2018, the surgeon thought that the cephalad positioned implant may have been too close to the neuroforamen and decided to remove it.In (b)(6) 2018, the surgeon performed a revision procedure where he first removed the cephalad implant, likely using chisels.He then attempted to place an iliosacral screw in the explant void but the screw broke and was subsequently removed leaving the screw washer unnoticed in the void.After placing a shorter implant of the same initial type into the void, the surgeon noticed the washer on interoperative x-rays, removed the implant and the washer and replaced the implant.He finally added an additional implant of the same type in a ventral position.No other preexisting implants were adjusted or removed.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: 7911570
• Report Number: 3007700286-2018-00079
• Device Sequence Number: 13802831
• Product Code: OUR
• UDI-Device Identifier: 00859256003309
• UDI-Public: 00859256003309
• 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): 09/10/2018

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: 12/22/2020
• Device Model Number: 7050-90
• Device Lot Number: 493594
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 09/26/2018
• 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: Required Intervention
• Patient Age: 52 YR