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 Problem Nervous System Injury (2689)

Event Date 11/11/2022

Event Type  Death  

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 publishing date of the literature article.Device lot number, or serial number, unavailable.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.Medical safety assesses the reported event of a patient experiencing a subarachnoid hemorrhage, subsequently leading to death and its reported severity as not related to the device or therapy, but potentially related to the migration of the k wire during surgery.There was no allegation of product deficiency.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

Sawarkar, d.P., singh, p.K., agrawal, d., satyarthee, g.D., gupta, d.K., tandon, v., gurjar, h.K., borkar, s., jagdevan, a., mishra, s., kedia, s., sharma, r., doddamani, r., verma, s., meena, r., kumar, r., chandra, r.S., kale, s.S.O-arm assisted anterior odontoid screw fixation in type ii and rostral type iii odontoid fractures: single center surgical series of 50 patients.Neurological society of india.2022.70 (s135-43).Doi: 10.4103/0028-3886.360924.Abstract: background: accuracy of screw placement is one of the important factors necessary for adequate union in odontoid fractures with malposition rates as high as 27.2% with standard techniques.Objective: to evaluate efficacy of intraoperative o-arm assistance in improving accuracy of anterior odontoid screw placement and cl inco-radiological outcome in type ii and iii odontoid fractures.Material and methods: in this retrospective study, surgery consisted of anterior odontoid screw fixation under intraoperative o-arm assistance over 5 years.Demographical, clinical, radiological, operative details and postoperative events were retrieved from hospital database and evaluated for fusion and surgical outcome.Results: 50 patients (mean age 34.6 years, sd 14.10, range: 7¿70 years; 44 males and 6 females) with type ii and type iii odontoid fracture underwent o-arm assisted anterior screw placement.The mean interval between injury and surgery was 12 days (range 1¿65 days).Mean operating time was 132.2 min ± sd 33.56 with average blood loss of 93 ml.±sd 61.46.With our technique, accurate screw placement was achieved in 100% patients.At the mean follow-up of 26.4 month (sd13.75), overall acceptable fusion rate was 97.8% with non-union in 2.2% patients.Morbidity occurred in two patients; one patient developed fixation failure while other patient had nonunion which was managed with posterior c1-c2 arthrodesis.We had surgical mortality in one patient due to sah.So overall our procedure was successful in 94% patients and among patients whose follow-up was available, acceptable fusion rates of 97.8% were achieved.Conclusion: we conclude that use of intraoperative three-dimensional imaging using o-arm for anterior odontoid screw fixation improves accuracy and leads to improved radiological and clinical outcomes.It further enables us to extend the indications of odontoid screw fixation to selected complex type ii and rostral type iii odontoid fractures.Reported events: one patient suffered proximal migration of the k wire during the procedure resulting subarachnoid hemorrhage (sah) revealed on posto perative ct head scan.Due to poor clinical condition, this patient could not be evaluated further and died probably due to neurovascular 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: 16004694
• MDR Text Key: 305710994
• Report Number: 3004785967-2022-00842
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 12/19/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/19/2022
• 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): Death; Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male