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 Imprecision (1307)

Patient Problems Muscle Weakness (1967); Unspecified Tissue Injury (4559)

Event Date 06/05/2021

Event Type  malfunction  

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patients 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 is therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacture date is dependent on the device lot/serial number, therefore is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: masato tanaka, venkatesh kadiri, sumeet sonawane, koji uotani, shinya arataki, yoshihiro fujiwara, yoshiaki oda , taro yamauchi, tomoyuki takigawa.Comparative evaluation of screw accuracy and complications of new c-arm free o-arm navigated minimally invasive cervical pedicle screw fixation (miceps) with conventional cervical screw fixation.Interdisciplinary neurosurgery: advanced techniques and case management 25 (2021).Https://doi.Org/10.1016/j.Inat.2021.101278 abstract: study design: retrospective comparative study.Objective: comparative study of c-arm free o-arm navigated minimally invasive cervical pedicle screw (miceps) fixation with conventional cervical pedicle screw fixation.Methods: twenty-five patients with different cervical spine pathologies were operated with miceps with o-arm navigation (group m; 18 patients) and conventional pedicle screw (group c; 7 patients) from june 2017 to january 2020.Operative time, blood loss were recorded.Preoperative and postoperative radiograms, ct scans and mri were evaluated.Postoperatively screw position accuracy and angulation was determined on ct.Breach rate was evaluated on ct scan and classified according to neo grading.Complications if any were noted.Results: the average blood loss in group m and group c was 129 ml and 329 ml, respectively.The average operative time in group m and group c was 77.4 min and 82.3 min, respectively.A total of 148 screws were inserted.In group m, no patient showed grade 2 and 3 breach while in group c, grade 0 and 1 breach was found in 85.7% screws and grade 2 in 14.3% screws.Mean screw medial angulation was 45.2 degrees in group m and 33.4 degrees in group c.There wasone dural tear and two c5 palsies in each group.Conclusion: with c -arm free o-arm navigated miceps fixation operative time and blood loss are less though not statistically significant.It has less pedicle breach rate, less incidence of neurovascular complications than conventional technique.There is no radiation exposure to operating surgeon and staff.Complications: 1) one patient experienced a dural tear that healed without consequences 2) two patients experienced a c5 palsy that recovered after two months.3) 15.1% of screws were found to have a non-significant grade 1 breach.

• 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
• MDR Report Key: 12410629
• MDR Text Key: 280775007
• Report Number: 3004785967-2021-01062
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 08/26/2021
• Initial Date FDA Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR