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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Paresthesia (4421); Unspecified Nervous System Problem (4426); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/16/2022

Event Type  Injury  

Event Description

Zhao, jianquan, et al.¿risk factors for the drift phenomenon in o-arm navigation-assisted pedicle screw placement during spinal deformity surgery.¿ orthopaedic surgery, 2022, https://doi.Org/10.1111/os.13557.Summary: objective: intraoperative o-arm navigation systems improve the accuracy of spinal instrumentation placement.However, deviation of the pedicle screw from the guide line might occur.The aim of the present study was to explore the causes of and countermeasures for the drift phenomenon during pedicle screw implantation with the aid of an o-arm three-dimensional navigation system in spinal deformity surgery.Methods: this was a retrospective analysis of 341 patients with spinal deformity who underwent o-arm navigation system-assisted pedicle screw placement from july 2015 to june 2019.The patient¿s general condition, cobb angle, apical vertebra position, softness index, spinal release status, fixed reference frame position, and distance between the navigation vertebral body and the reference frame were collected and compared by independent-samples t test or pearson¿s chi-square analysis.The potential risk factors for the drift phenomenon were identified using binary logistic regression analysis.Results: the drift phenomenon occurred in 57 patients during the first navigation-assisted pedicle screw placement, for an incidence of 16.7% (57/341).There were significant differences in factors such as the apical vertebra position, softness index, spinal release status, and distance between the vertebral body and the reference frame when the drift phenomenon occurred (p <(><<)> 0.05).Binary logistic regression analysis showed that the softness index, spinal release status, and distance between the vertebral body and the reference frame when drifting occurred were independent risk factors for the drift phenomenon during o-arm navigation-assisted pedicle screw placement.Conclusions: during the use of an o-arm navigation system to assist with pedicle screw placement, pedicle screws should not be placed away from the reference frame, and spinal osteotomy and release should be performed after pedicle screw placement.In addition, the accuracy of o-arm navigation-assisted pedicle screw placement will be affected more in those with larger softness indices.Reported event: 1.Perioperative complications occurred in 17 patients.Two patients experienced the transient disappearance of somatosensory evoked potentials (seps) and motor evoked potentials (meps) during surgery.One patient experienced postoperative paresthesia and movement disorders in both lower extremities.This patient¿s muscle strength returned to grade 4 at the follow-up 3 months later.Additionally, minor trunk displacement occurred in six patients.2.The deviation of the pedicle screw guide line from the true pedicle was defined as ¿drift¿ after errors and inaccuracies in use were excluded.That is, the screen navigation guide line was in the pedicle, but the pedicle ball scout indicated damage to the pedicle wall.In our study, 16.7% (57/341) of patients experienced drift during pedicle screw implantation.After the intraoperative detection of drift, we immediately performed another scan and re-established the reference frame to prevent drift-induced pedicle screw misplacement.Therefore, the incidence of navigation-assisted pedicle breach in our study was 1.7% ((b)(4)).See literature article.

Manufacturer Narrative

Patient information was not included in the journal entry.This value reflects the mean age of the patients who underwent surgery, as specific patients could not be identified.This value reflects the majority gender of the patients who underwent surgery, as specific patients could not be identified.The article did not provide the date of the procedure.The event date provided is the article accepted date.The article citation is included.The system product number and serial number were not provided in the journal article.No 510k provided as system is unknown.No evaluation was performed as the event was reported as a literature article.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.

• 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: 15970066
• MDR Text Key: 305361842
• Report Number: 3004785967-2022-00827
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK_OARM_SYS
• Device Catalogue Number: UNK_OARM_SYS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/13/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 21 YR
• Patient Sex: Female