MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM IMAGING SYSTEM; 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 Cerebrospinal Fluid Leakage (1772); Nerve Damage (1979); Tissue Damage (2104)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

Weight: patient weight not available from the site.Lot #, serial #: device lot number, or serial number, unavailable.Pma/510k #: 510(k) is unavailable as the device serial number is unavailable.Device evaluated by mfr: no parts have been received by the manufacturer for evaluation.Manufacture date: device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: bing-tao wen, md.Zhong-qiang chen, md.Chui-guo sun, md.Kai-ji jin, md.Jun zhong, md.Xin lui, md.Lei tan, md, peng yang, md, geri le, md, man luo, md.Three-dimensional navigation (o-arm) versus fluoroscopy in the treatment of thoracic spinal stenosis with ultrasonic bone curette.Medicine (2019) 98: 20 (e15647).Summary: abstract: three-dimensional intraoperative navigation (o-arm) has been used for many years in spinal surgeries and has significantly improved its precision and safety.This retrospective study compared the efficacy and safety of spinal cord decompression surgeries performed with o-arm navigation and fluoroscopy.The clinical data of 56 patients with thoracic spinal stenosis treated from march 2015 to april 2017 were retrospectively analyzed.Spinal decompression was performed with o-arm navigation and ultrasonic bone curette in 29 patients, and with ultrasonic bone curette and fluoroscopy in 27 patients.Patients were followed-up at postoperative 1 month, 3 months, and the last clinic visit.The neurologic functions were assessed using the japanese orthopaedic association (joa) back pain evaluation questionnaire.The accuracy of screw placement was examined using three-dimensional computed tomography (ct) on postoperative day 5.There was no significant difference in the incidences of intraoperative dural tear, nerve root injury, and spinal cord injury between the two groups.The two groups showed no significant difference in postoperative joa scores (p>.05).The o-arm navigation group had significantly higher screw placement accuracy than the fluoroscopy group (p<.05).O-arm navigation is superior to fluoroscopy in the treatment of thoracic spinal stenosis with ultrasonic bone curette in terms of screw placement accuracy.However, the two surgical modes have similar rates of intraoperative complications and postoperative neurologic functions.Reported events: 6 patients experienced a dural tear or cerebrospinal fluid (csf) leak due to adhesion between the ligaments and the dura.None of the dural tears were noted to have been caused by inappropriate use of the ultrasonic bone curette.2 patients experienced nerve root damage due to the ultrasonic bone curette as the ossified part of the ligament was excessively large, and the spinal stenosis was noted to be severe resulting in a narrow space between the ossified part of the ligament and the posterior border of the vertebral body.

• Brand Name: O-ARM IMAGING SYSTEM
• 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: 8811678
• MDR Text Key: 151733617
• Report Number: 3004785967-2019-01273
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2019

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: 06/23/2019
• Initial Date FDA Received: 07/22/2019
• 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: 53 YR