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 Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Unspecified Tissue Injury (4559)

Event Date 01/01/2009

Event Type  malfunction  

Event Description

Contreras a., batke j., dea n., dvorak m.F.S., fisher c.G.Street j.Intraoperative cone beam ct (o-arm) and stereotactic navigation (stealthstation) system in complex adult spine surgery-early experience and learning curve.Canadian medical association journal.2015.58 (3) (s67-s68) abstract background: there is limited data evaluating the clinical learning curve for surgeons and its relationship to patient outcomes when using intraoperative navigation and imaging systems.We examined the clinical learning curve and patient outcomes of using o-arm and stealthstation for 6 fellowship-trained spine surgeons at our institution, a single quaternary referral centre, from 2009-2013.Methods: this ambispective study examined 231 surgical cases where o-arm and stealthstation were used to facilitate pedicle instrumentation.The learning curve was determined by examining total operative time and blood loss, operative time and blood loss per surgical level and the incidence of surgery-related adverse events (aes) by year.The aes were prospectively collected using the spine adverse events severity system (saves).Results: at our institution, all spine surgeons were using o-arm and stealthstation by the beginning of 2009.A total of 231 patients had screws placed using the o-arm and stealthstation between jan.1, 2009, and dec.31, 2012.The number of screws placed increased significantly from 430 screws placed in 27 cases in 2009 to 758 screws in 75 cases in 2012 (p <(><<)> 0.05).The average estimated blood loss (ebl) decreased from 1229 ml in 2009 to 907 ml in 2012 (p <(><<)> 0.05).The ebl per case per number of levels instrumented decreased from 5.72 ml in 2008 to 2.39 ml in 2012 (p <(><<)> 0.05).Mean operating time decreased from 407 to 378 minutes (p <(><<)> 0.05).The number of misplaced screws per case decreased from 0.78 to 0.54 from 2009 to 2012 (p <(><<)> 0.05).There were no significant differences in incidences of dural tear, surgical site infection or other surgical aes over the study period.Conclusion: our results demonstrate that there is a learning curve to the use of intraoperative ct-based navigation, as measured by or time, intraoperative blood loss and screw malposition.There were no significant differences in surgical aes during this learning period.Reportable events: the average estimated blood loss (ebl) decreased from 1229 ml in 2009 to 907 ml in 2012 (p <(><<)> 0.05) the number of misplaced screws per case decreased from 0.78 to 0.54 from 2009 to 2012 (p <(><<)> 0.05) there were no significant differences in incidences of dural tear, surgical site infection or other surgical aes over the study period.

Manufacturer Narrative

Patient information was unavailable from the site.Event date is the estimated date the event took place.Device lot number, or serial number, unavailable.The facility where the reported issue occurred is unknown.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 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.

Manufacturer Narrative

H3) correction to d3.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.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.

• 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 CO 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton,ma CO 01460
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15580880
• MDR Text Key: 301637292
• Report Number: 1723170-2022-01631
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/20/2022

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: 10/05/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 12/20/2022
• 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