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 Imprecision (1307)

Patient Problems Unspecified Tissue Injury (4559); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2023

Event Type  malfunction  

Manufacturer Narrative

A1-a5; patient information was not included in the journal entry a2; this value reflects the mean age of the patients who underwent spinal surgery as specific patients could not be identified.A3; this value reflects the majority gender of the patients who underwent spinal surgery as specific patients could not be identified.B3; the article did not provide the date of the procedure.The event date provided is the accepted date.B5; the article citation is included.D4; the system product number and serial number were not provided in the journal article.Udi not available for this system.G2; no 510k provided as system is unknown.H3; no evaluation was performed as the event was reported as a literature article.H4; device manufacturing date is unavailable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: mota, f., welch, n., montgomery, b.K., birch, c., <(>&<)>amp; hedequist, d.(2023).Use of a high-speed drill in robotics coupled with navigation for pediatric spine surgery.Journal of robotic surgery.Https://doi.(b)(6) abstract: with the increasing number of surgeries for pediatric spinal deformities, the aim has been to reduce the associated complications, s uch as those caused by screw malposition.This case series is an intra-operative experience with a new navigated high-speed revolution drill (mazor midas, medtronic, minneapolis, mn) for pediatric spinal deformity to assess accuracy and workflow.88 patients, ranging from 2 to 29 years of age, were included who underwent posterior spinal fusion with the navigated high-speed drill.Diagnoses, cobb angles, imaging, surgical time, complications, and total number of screws placed are described.Screw positioning was evaluated using fluoroscopy, plain radiography, and ct.Mean age was 15.4 years old.Diagnoses included 47 adolescent idiopathic scoliosis, 15 neuromuscular scoliosis, 8 spondylolisthesis, 4 congenital scoliosis, and 14 other.The mean cobb angulation for scoliosis patients was 64° and the mean number of levels fused was 10.81 patients had registration via intraoperative 3-d imaging and 7 had pre-operative ct scan to fluoroscopy registration.There were a total of 1559 screws with 925 placed robotically.927 drill paths were drilled with the mazor midas.926 out of 927 drill paths were accurate.The mean surgical time was 304 min with the mean robotic time being 46 min.This is the first intra-operative report to our knowledge documenting the experience with the mazor midas drill in pediatric spinal deformity showing decreased skiving potential, decreased torque when drilling, and lastly increased accuracy.Level of evidence: level iii.: reported event: 1.88 patients underwent spinal surgery, with a total of 1559 screw that were placed.1 out of 926 had inaccurate screw trajectory.This was due to the registration being inaccurate.2.88 patients underwent spinal surgery, with a total of 1559 screw that were placed.2 out of 927 had inaccurate screw placement.See attached literature article.

• 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: 16814479
• MDR Text Key: 314000708
• Report Number: 3004785967-2023-00250
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 04/17/2023
• Initial Date FDA Received: 04/26/2023
• 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 Age: 15 YR
• Patient Sex: Female