MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) MEDTRONIC NAVIGATION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number UNK_OARM_SYS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Pain (1994); Swelling (2091); Thrombosis (2100); Foreign Body In Patient (2687)

Event Date 12/18/2019

Event Type  Injury  

Manufacturer Narrative

Please note the patient age is the average age of patients in o-arm navigation group for the article and the patient gender is the majority gender of patients in the o-arm navigation group for the article.The specific age and gender of two of the patients with reported events are specified.Patient weights were not included in the journal article.Please note that this date is based off of the date the article was published as the event dates were not provided in the published literature.Article citation is included.System product number and serial number not provided in journal article.Udi not available for this system.No 510k provided as system is unknown.No evaluation was performed as this event was reported in literature.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: zhang, yijian, et al.¿safety and efficacy of percutaneous kyphoplasty assisted with o-arm navigation for the treatment of osteoporotic vertebral compression fractures at t6 to t9 vertebrae.¿ international orthopaedics (sicot) (2019) 18 dec.2019, doi:https://doi.Org/10.1007/s00264-019-04444-5.Abstract: purpose: to evaluate the safety and efficacy of pkp under o-arm navigation system guidance for treating middle thoracic ovcf (t6~t9).Methods: a retrospective study was conducted for 44 consecutive t6~t9 ovcf patients who received pkp assisted with o-arm navigation (n = 20) or fluoroscopy (n = 24) from january 2016 to december 2017.Demographic data, radiographic parameters, and clinical outcomes were collected and analyzed at pre operative, post-operative, and final follow-up period.Complications including tissue lesion, needle malposition, and leakage of bone cement were also recorded amid operation.Results: a total of 44 patients (4 males and 40 females, with mean age of 71.1 ± 8.7) were enrolled in this study, and the mean follow-up time was 14.4 months.In surgical details, navigation system could obtain more satisfactory volume of injected cement and less loss of blood, as well did not increase surgical time compared with fluoroscopy.Both radiological and clinical outcomes improved significantly at post-operative and final follow-up, while did not differed between two groups.For adverse events, the incidence of cement leakage was similar between two groups.However, o-arm navigation can achieve lower rate of complications than fluoroscopy.Conclusion: our preliminary study demonstrated that pkp assisted with o-arm navigation is a safe and effective procedure that applied for middle thoracic ovcf (t6~t9), which can achieve favourable radiological and clinical outcomes, and low rate of complications.Reported events: one patient in the o-arm navigation group had cement leakage on post-operative x-ray radiographs.However, this patient had no clinical symptoms after surgery and during follow-up.A (b)(6)-year old female in the o-arm navigation group had pneumonia at one day post-operatively.It was noted that her symptoms were not severe and gradually recovered after the treatment of antibiotics and atomizer.An (b)(6)-year old female in the o-arm navigation group was diagnosed as dvt via ultrasonic examination, who complained of pain and had a swollen right leg.After the combined therapy of mechanical (intermittent pneumatic compression) and chemical (low-molecular-weight heparin), the patient's symptoms disappeared within one week after surgery.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9575863
• MDR Text Key: 178750843
• Report Number: 3004785967-2020-00047
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2020

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: 01/02/2020
• Initial Date FDA Received: 01/10/2020
• 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; Required Intervention
• Patient Age: 70 YR