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 Hemorrhage/Bleeding (1888); Nervous System Injury (2689); Insufficient Information (4580)

Event Date 06/15/2021

Event Type  Injury  

Manufacturer Narrative

Patient information was not included in the journal entry.This value reflects the average age of the patients who underwent the posterior wedge osteotomy as specific patients could not be identified.This value reflects the majority gender of the patients who underwent the posterior wedge osteotomy as specific patients could not be identified.The article did not provide the date of the procedure.The event date provided is the accepted date.The article citation is included.The serial number was not provided in the journal article.Udi not available for this system.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Li, bo, et al.¿posterior wedge osteotomy assisted by o-arm navigation for treating ankylosing spondylitis with thoracolumbar fractures: an early clinical evaluation.¿ annals of palliative medicine, 2021, https://doi.Org/10.21037/apm-21-1286.Summary background: to explore the feasibility and efficiency of posterior wedge osteotomy assisted by o-arm navigation treatment of ankylosing spondylitis (as) patients with thoracolumbar fracture.Methods: this is a case series study.A total of 16 cases of as accompanied by thoracolumbar fractures from january 2012 to july 2015 were retrospectively analyzed.All patients underwent ¿posterior wedge osteotomy assisted by o-arm navigation¿.The operation time, blood loss volume, preoperative and postoperative visual analogue scale (vas), american spinal injury association (asia) classification, and spinal imaging parameters [cobb angle, c7 plumb line (c7pl), and jaw-brow angle] were collected and analyzed.Results: the operative time consumption was 120¿350 mins and the intra-operative blood loss volume was 200¿800 ml.No obvious postoperative complications occurred in any participants.The back pain of all participants was relieved, and the neurological functions of eight participants with spinal cord injury (sci) were recovered in varying degrees except for one patient with severe sci.The spinal deformities of the participants were corrected to varying degrees.The fracture sites of 16 participants were all healed, and there was no loosening or detachment of internal fixation during the 6-month follow-up period.Conclusions: posterior wedge osteotomy assisted by o-arm navigation was shown to be a safe and effective method to treat as accompanied by thoracolumbar fractures.This treatment strategy can accurately decompress and reduce the fracture and significantly correct the kyphosis, with good surgical effect.Reported events: sixteen patients with ankylosing spondylitis due to thoracolumbar fracture underwent a posterior wedge osteotomy that was assisted by an imaging system.It was reported that patients that bled over 1,500 ml and had a surgical time over 3 hours were treated with antibiotics for one to two days after the surgery.Patients with spinal cord injury(sci) were treated with drugs to address dehydration and provide nerve nutrition.It was also noted that one patient had a longer operation time and their bleeding volume reached 800 ml.This caused the site to perform an autologous blood transfusion.Another patient was experienced a sci during the operation.After the screw was replaced and postoperative hormone application, the patient had no neurological damage postoperatively.

• 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: 12860906
• MDR Text Key: 281144864
• Report Number: 3004785967-2021-01310
• 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: Physician
• Type of Report: Initial
• Report Date: 11/23/2021

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: 11/17/2021
• Initial Date FDA Received: 11/23/2021
• 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; Other
• Patient Age: 43 YR
• Patient Sex: Male