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 Muscle Weakness (1967); Nerve Damage (1979); Unspecified Nervous System Problem (4426); Unspecified Tissue Injury (4559)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patient in the study.Patient weight not available from the site.Event date is the online accepted date of the literature article.Device lot number, or serial number, unavailable.510(k) is dependent upon the device model number and therefore, unavailable.Device evaluated by mfr: 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.

Event Description

Mao, g., elhamdani, s., gigliotti, m.J., mace, a., sclabassi, r., oh, m., whiting, d.Neurologic complications in monitored versus unmonitored image-guidance assisted posterior lumbar instrumentation.World neurosurg.2021.152 (e155-e160) https://doi.Org/10.101 6/j.Wneu.2021.05.074 background: intraoperative neurophysiologic monitoring (iom) has been used clinically since the 1970s and is a reliable tool for detecting impending neurologic compromise.However, there are mixed data as to whether long-term neurologic outcomes are improved with its use.We investigated whether iom used in conjunction with image guidance produces different patient outcomes than with image guidance alone.Methods: we reviewed 163 consecutive cases between january 2015 and december 2018 and compared patients undergoing posterior lumbar instrumentation with image guidance using and not using multimodal iom.Monitored and unmonitored surgeries were performed by the same surgeons, ruling out variability in intersurgeon technique.Surgical and neurologic complication rates were compared between these 2 cohorts.Results: a total of 163 patients were selected (110 in the nonmonitored cohort vs.53 in the iom cohort).Nineteen signal changes were noted.Only 3 of the 19 patients with signal changes had associated neurologic deficits postoperatively (positive predictive value 15.7%).There were 5 neurologic deficits that were observed in the nonmonitored cohort and 8 deficits observed in the monitored cohort.Transient neurologic deficit was significantly higher in the monitored cohort per case (p <(><<)> 0.0198) and per screw (p <(><<)> 0.0238); however, there was no difference observed between the 2 cohorts when considering permanent neurologic morbidity per case (p <(><<)> 0.441) and per screw (p <(><<)> 0.459).Conclusions: the addition of iom to cases using image guidance does not appear to decrease long-term postoperative neurologic morbidity and may have a reduced diagnostic role given availability of intraoperative image-guidance systems.Reported events: one patient required removal of a pedicle screw following pedicle stimulation 1 patient required repositioning of 1 screw and removal of another following emg burst activity only 3 of the 19 iom cases with intraoperative changes had associated neurologic changes afterward.Direct surgical intervention was documented in response to iom changes in 1 case.This was a patient with baseline hip flexion and knee extension weakness and prior lumbar decompression who required an l1 to s1 laminectomy and posterior lumbar fusion.After the second o-arm computed tomography was performed and reviewed, the surgical field was inspected and the right s1 screw was removed.Both patients with permanent deficits experienced dorsiflexion weakness consistent with lumbar root injury.

• 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: 16139219
• MDR Text Key: 307107438
• Report Number: 3004785967-2023-00032
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2023

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: 01/06/2023
• Initial Date FDA Received: 01/11/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male