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

Model Number 7035M-90

Device Problem Loss of Osseointegration (2408)

Patient Problem Arthralgia (2355)

Event Date 12/29/2021

Event Type  Injury  

Event Description

The patient is osteoporotic.The patient had left side si joint arthrodesis in (b)(6) 2020 where three implants were installed.The patient later complained of a recurrence of si-joint pain symptoms.The surgeon thought that the inferior positioned implant may have been loose.In (b)(6) 2021, the surgeon performed a revision procedure where he removed the inferior positioned implant and added a new implant of a different type in a more anterior position from the initial implant.The status of the patient following the revision procedure is unknown.

Manufacturer Narrative

Based on the information provided, review of the surgical technique manual, ifu, certificates of conformance 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 implant late loosening.The patient's condition, osteoporosis, may have contributed to the perceived loosening.

• 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: 13335097
• MDR Text Key: 289003348
• Report Number: 3007700286-2021-00149
• Device Sequence Number: 1
• Product Code: OUR
• UDI-Device Identifier: 00851085007305
• UDI-Public: 00851085007305
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193524
• 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: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7035M-90
• Device Lot Number: 2728291
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• 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): Other
• Patient Age: 71 YR
• Patient Sex: Female