MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC RIALTO SI FUSION SYSTEM; SACROILIAC JOINT FIXATION

Model Number MSB_UNK_RIALTO_IMP

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

Patient Problems Ossification (1428); Post Operative Wound Infection (2446)

Event Date 11/13/2018

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: ms b_unk_rialto_imp, serial/lot #: unknown, ubd: unknown, udi#: unknown.Authors:sharad rajpal and sigita burneikiene minimally invasive sacroiliac joint fusion with cylindrical threaded implants using intraoperative stereotactic navigation citation: world neurosurg.(2019) 122:e1588-e1591.Https://doi.Org/10.1016/j.Wneu.2018.11.116 a2:this value is the average age of the patients reported in the article as specific patients could not be identified.A3a: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.B3: date that the article was accepted for as the event dates were not provided in the published literature.D4: product identifiers are unknown.H6: neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.G3: 510(k)# is unknown.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Narrative: significant progress in hardware and surgical techniques for sacroiliac joint (sij) fusion surgeries has facilitated safer and more efficacious procedures for patients.Triangular-shaped implants for sij fusions are the most-studied devices and have demonstrated good short-term and long-term clinical outcomes. reports on cylindrical threaded implants are very limited. owing to biomechanical differences in the implants and the surgical techniques required for their placement, previously reported results may not be applicable to cylindrical threaded implants.The aim of this study was to report preliminary clinical experience with minimally invasive sij fusion using intraoperative stereotactic navigation and the rialto si fusion system.  the study included 24 patients who underwent sij fusion between (b)(6) 2015 and (b)(6) 2017 performed by (b)(6) sij disruption or sacroiliitis was diagnosed in all patients, and the patients underwent at least 6 months of conservative treatment.Clinical diagnosis was established based on extensive physical examination, provocative sij pain tests, imaging studies, and confirmation via diagnostic sij injections performed using fluoroscopic guidance.Complications: 2 patients had symptomatic subcutaneous hematomas, which resolved spontaneously 2 patients had superficial wound infections treated with antibiotics.One patient developed an osteophyte on the lateral aspect of the implant.Because of symptomatic pain localized to that area, an ost eophytectomy was performed 1 year after the index surgery with an improvement in patient symptoms.

• Brand Name: RIALTO SI FUSION SYSTEM
• Type of Device: SACROILIAC JOINT FIXATION
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 18948057
• MDR Text Key: 338187413
• Report Number: 1030489-2024-00148
• Device Sequence Number: 1
• Product Code: OUR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_RIALTO_IMP
• Device Catalogue Number: MSB_UNK_RIALTO_IMP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• 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
• Treatment: "SEE H11...."
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female