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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2023

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 the scoliosis surgery as specific patients could not be identified.A3) this value reflects the majority gender of the patients who underwent the scoliosis surgery as specific patients could not be id entified.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

Li, c., wang, z., li, d., tian, y., yuan, s., wang, l., <(>&<)>amp; liu, x.(2023).Safety and accuracy of cannulated pedicle screw placement in scoliosis surgery: a comparison of robotic-navigation, o-arm-based navigation, and freehand techniques.European spine journal.Https://doi.Org/10.1007/s00586-023-07710-8 summary: purpose: to compare the safety and accuracy of cannulated pedicle screw placement using a robotic-navigation technique, o-arm-based navigation technique, or freehand technique.Methods: this study analyzed 106 consecutive patients who underwent scoliosis surgery.Thirty-two patients underwent robotic-navigat ion-assisted pedicle screw insertion (group 1), 34 patients underwent o-arm-based navigation-guided pedicle screw insertion (group 2), and 40 patients underwent freehand pedicle screw insertion (group 3).The primary outcome measure was the accuracy of screw placement.Secondary outcome parameters included operation time, blood loss, radiation exposure, and postoperative stay.Results: a total of 2035 cannulated pedicle screws were implanted in 106 patients.The accuracy rate of the first pedicle screw placement during operation was significantly greater in group 1 (94.7%) than in group 2(89.2%; p<(><<)>0.001).The accuracy rate of pedicle screw placement postoperatively decreased in the order of group 1 (96.7%)> group 2 (93.0%)>group 3 (80.4%; p0.05).There were no significant differences in blood loss or postoperative stay among the three groups (p>0.05).The operation times of group 1 and group 2 were significantly longer than that of group 3 (p<(><<)>0.05).Conclusions: the robotic-navigation and o-arm-based navigation techniques effectively increased the accuracy and safety of pedicle s crew insertion alternative to the freehand technique in scoliosis surgery.Compared with the o-arm-based navigation technique, the robotic-navigation technique increases the mean operation time, but also increases the accuracy of pedicle screw placement.A three-dimensional scan after insertion of the k-wire may increase the accuracy of pedicle screw placement in the o-arm-based navigation technique.Reported events: 1.Thirty-two patients with scoliosis underwent scoliosis surgery using robotic navigation.6.7% of the screw that were placed were considered grade b (perforation <(><<)>2 mm).2.Thirty-two patients with scoliosis underwent scoliosis surgery using robotic navigation.1.4% of the screw that were placed were considered grade c (perforation =2 to<(><<)>4 mm).3.Thirty-two patients with scoliosis underwent scoliosis surgery using robotic navigation.1.9% of the screw that were placed were considered grade d (perforation n=4 to<(><<)>6 mm).4.Thirty-four patients with scoliosis underwent scoliosis surgery using o-arm-based navigation.10.1% of the screw that were placed were considered grade b (perforation <(><<)>2 mm).5.Thirty-four patients with scoliosis underwent scoliosis surgery using o-arm-based navigation.5.4% of the screw that were placed were considered grade c (perforation =2 to<(><<)>4 mm).6.Thirty-four patients with scoliosis underwent scoliosis surgery using o-arm-based navigation.1.3% of the screw that were placed were considered grade d (perforation n=4 to<(><<)>6 mm).7.Thirty-four patients with scoliosis underwent scoliosis surgery using o-arm-based navigation.0.3% of the screw that were placed were considered grade e (perforation = 6 mm).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: 17424720
• MDR Text Key: 320074609
• Report Number: 3004785967-2023-00464
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• 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
• Date Manufacturer Received: 07/26/2023
• 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