MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M

Model Number UNK_OARM_SYS

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

Patient Problems Hemorrhage/Bleeding (1888); Loss of Range of Motion (2032); Unspecified Tissue Injury (4559)

Event Date 02/07/2024

Event Type  Injury  

Manufacturer Narrative

Event date is the accepted date of the literature article.D4) device lot number, or serial number, unavailable.G4) 510(k) is dependent upon the device model number and therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.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

Chang, p.L., chen, m.J.W., hsiao, p.H., lin, c.Y., lo, y.S., tseng, c., li, l.Y., lai, c.Y., chen, h.T.Navigation-assisted one-staged posterior spinal fusion using pedicle screw instrumentation in adolescent idiopathic scoliosis¿a case series.Medicina 2024, 60, 300.Https://doi.Org/10.3390/medicina60020300 abstract: background and objectives: adolescent idiopathic scoliosis (ais) is a prevalent three-dimensional spinal disorder, with a multifactorial pathogenesis, including genetics and environmental aspects.Treatment options include non-surgical and surgical treatment.Surgical interventions demonstrate positive outcomes in terms of deformity correction, pain relief, and improvements of the cardiac and pulmonary function.Surgical complications, including excessive blood loss and neurologic deficits, are reported in 2.27¿12% of cases.Navigation-assisted techniques, such as the o-arm system, have been a recent focus with enhanced precision.This study aims to evaluate the results and complications of one-stage posterior instrumentation fusion in ais patients assisted by o-arm navigation.Materials and methods: this retrospective study assesses 55 patients with ais (12¿28 years) who underwent one-stage posterior instrumentation correction supported by o-arm navigation from june 2016 to august 2023.We examined radiological surgical outcomes (initial correction rate, loss of correction rate, last follow-up correction rate) and complications as major out-comes.The characteristics of the patients, intraoperative blood loss, operation time, number of fusion levels, and screw density were documented.Results: of 73 patients, 55 met the inclusion criteria.The average age was 16.67 years, with a predominance of females (78.2%).The surgical outcomes demonstrated substantial initial correction (58.88%) and sustained positive radiological impact at the last follow-up (56.56%).Perioperative complications, including major and minor, occurred in 18.18%of the cases.Two patients experienced a major complication.Blood loss (509.46 ml) and operation time (402.13 min) were comparable to the literature ranges.Trend analysis indicated improvements in operation time and blood loss over the study period.Conclusions: o-arm navigation-assisted one-stage posterior instrumentation proves reliable for ais corrective surgery, achieving significant and sustained positive radiological outcomes, lower correction loss, reduced intraoperative blood loss, and absence of impl ant-related complications.Despite the challenges, our study demonstrates the efficacy and maturation of this surgical approach.Reportable events: allogenic blood transfusions were administered in 3 out of 55 cases one cases had brachial plexus injury one case progress to postoperative alignment decompensation that required revision surgery.See attached literature article.

Manufacturer Narrative

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

Additional information was received.It was reported that medtronic device did not cause or contribute to the reported events.

• Brand Name: O-ARM IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19098270
• MDR Text Key: 340100456
• Report Number: 3004785967-2024-00248
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

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
• Device Operator: Health Professional
• Device Model Number: UNK_OARM_SYS
• Device Catalogue Number: UNK_OARM_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 49 KG