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

Model Number 7040M-90

Device Problem Malposition of Device (2616)

Patient Problem Arthralgia (2355)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, review of the surgical technique manual, certificates of conformance, ifu 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: using too long of an implant or not installing the implant deep enough.

Event Description

The patient had left si joint arthrodesis in (b)(6) 2018 where three implants were installed.The patient later complained of left side hip pain.The surgeon determined that the inferior positioned implant was too proud of the ilium causing pain in the surrounding tissue.The surgeon did not indicate that any of the implants were loose.In (b)(6) 2019, the surgeon performed a revision procedure where he removed the inferior positioned implant using chisels as it was solidly fixed in bone.No other preexisting implants were adjusted or removed.The patient's pain symptoms resolved following the revision procedure.

• Brand Name: IFUSE IMPLANT SYSTEM
• Type of Device: ORTHOPEDIC ROD
• Manufacturer (Section D): SI-BONE, INC.; 471 el camino real; suite 101; santa clara CA 95050 4482
• Manufacturer (Section G): SI-BONE, INC.; 471 el camino real; suite 101; santa clara CA 95050 4482
• Manufacturer Contact: w. reckling, m.d. ; 471 el camino real; suite 101; santa clara, CA 95050-4482 ; 4082070700
• MDR Report Key: 9457995
• MDR Text Key: 177389859
• Report Number: 3007700286-2019-00153
• Device Sequence Number: 1
• Product Code: OUR
• UDI-Device Identifier: 00851085007343
• UDI-Public: 00851085007343
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2022
• Device Model Number: 7040M-90
• Device Lot Number: 2624931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR