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

Model Number SEE SECTION H.10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Insufficient Information (4580)

Event Date 09/09/2022

Event Type  Death  

Event Description

The patient was scheduled for a bilateral si joint arthrodesis procedure on (b)(6) 2022 for sacral fracture fixation.The patient was an 80 year old female who was small in stature and malnourished.The patient had also been hospitalized for two weeks prior to the sacral fixation/fusion procedure.On (b)(6) 2022, the patient was put under anesthesia in preparation for the procedure.The surgery team had difficulty getting globus robotic system to work which delayed the procedure for 2-3 hours while the patient was still under anesthesia.After getting the globus robotic system working, the surgeon was able to install two implants on each side.Installation took about 40 minutes.Shortly after the procedure the patient the patient coded with noted low blood pressure and died approximately 40 minutes after surgery.Relatedness to the implants cannot be established.The patient had multiple risk factors for death, including frailty due to old age, malnutrition, and weight loss due to prolonged immobility, prolonged hospitalization, and prolonged anesthesia.

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.Relatedness to the implants cannot be established.The patient had multiple risk factors for death, including frailty due to old age, malnutrition, and weight loss due to prolonged immobility, prolonged hospitalization, and prolonged anesthesia.(part number, lot number, manufacturing date, expiration date and udi/gtin number if applicable) left 1st (superior): ifuse torq, p/n 10065t, lot# 9054811, mfd.03/10/22, exp.2027-03-10, gtin (b)(4).Left 2nd (inferior): ifuse torq, p/n 10055t, lot# 9054321, mfd.01/14/22, exp.2027-01-14, gtin (b)(4).Right 1st (superior): ifuse torq, p/n 10065t, lot# 9046771, mfd.09/22/21, exp.2026-09-22, gtin (b)(4).Right 2nd (inferior): ifuse torq, p/n 10055t, lot# 9054321, mfd.01/14/22, exp.2027-01-14, gtin (b)(4).

• Brand Name: IFUSE TORQ 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: 15592288
• MDR Text Key: 301623731
• Report Number: 3007700286-2022-00007
• Device Sequence Number: 1
• Product Code: OUR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SEE SECTION H.10
• Device Lot Number: SEE SECTION H.10
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 80 YR
• Patient Sex: Female