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 Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Pain (1994)

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

H3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.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

Citation: world neurosurg.(2024) 184:e546-e553.Https://doi.Org/10.1016/j.Wneu.2024.01.168 summary: objective: we describe the incidence of, and identify the risk factors for, a medial breach of the pedicle wall during robotic-assisted cortical bone trajectory (ra-cbt) screw insertion.Methods: we analyzed a consecutive series of adult patients who underwent ra-cbt screw placement from january 2019 to july 2022.To assess the pedicle wall medial breach, postoperative computed tomography (ct) images were analyzed.Patient demographic data and screw data were compared between patients with and without a medial breach.The hounsfield units (hus) on the l1 midvertebral axial ct scan was used to evaluate bone quality.Results: of 784 cbt screws in 145 patients, 30 (3.8%) had a medial breach in 23 patients (15.9%).One screw was grade 2, and the others were grade 1.Patients with a medial breach had a lower hu value compared with the patients without a medial breach (123.3 vs.150.5; p [0.027).A medial breach was more common in the right than left side (5.5% vs.2.0%; p [ 0.014).More than one half of the screws with a medial breach were found in the upper instrumented vertebra (uiv) compared with the middle construct or lowest instrumented vertebra (6.7% vs.1.3% vs.2.7%; p[0.003).Binary logistic regression showed that low hu values, right-sided screw placement, and uiv were associated with a medial breach.No patients returned to the operating room for screw malposition.No differences were found in the clinical outcomes between patients with and without a medial breach.Conclusions: the incidence of pedicle wall medial breach was 3.8% of ra-cbt screws in the postoperative ct images.A low hu value measured in the l1 axial image, right-sided screw placement, and uiv were associated with an increased risk of medial breach for ra-cbt screw placement.Reported events: this study reviewed the placement of 784 screws in 145 patients.The patients were stratified into two groups - patients with and without a medial breach, the latter being the control group.30 screws had a medial breach in 23 patients.Of these, one was grade 2 (screw totally passed the medial pedicle cortex) and 29 were grade 1 (>1/2 of the screw diameter passed the medial pedicle cortex).There were 10 screws that resulted in a lateral breach, two grade 2 (screw totally passed the lateral pedicle cortex) and eight grade 1 (?1/2 of the screw diameter passed the lateral pedicle cortex).There were 15 screws that results in an anterior breach, 6 and end plate breach, and 6 a foramen breach.It was noted that "some" lateral or anterior breaches were intentional.No patients with a medial breach visited the emergency department for pain management, however, patients in the control group did within 30 days after surgery.

• 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: 19130326
• MDR Text Key: 340447362
• Report Number: 3004785967-2024-00256
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2024

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?: Yes
• 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: 04/10/2024
• Initial Date FDA Received: 04/18/2024
• 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; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male