MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) IMAGING SYSTEM

Model Number UNK_OARM_SYS

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

Patient Problems Seroma (2069); Tissue Damage (2104); Complaint, Ill-Defined (2331); Post Operative Wound Infection (2446)

Event Date 12/16/2017

Event Type  Injury  

Manufacturer Narrative

Patient information was not included in the journal article.This value is the mean age of the patients who underwent o-arm based navigation system-assisted spinal fixation in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients who underwent o-arm based navigation system-assisted spinal fixation in the article as specific patients could not be identified.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: fan y, du j, zhang j, liu s, xue x, huang y, zhang j, hao d.Comparison of accuracy of pedicle screw insertion among 4 guided technologies in spine surgery.Medical science monitor.2017.Volume 23: 5960-5968.Doi: 10.12659/msm.905713 summary: background: as an available new tool for spinal surgery, robotic technology holds great potential and has been demonstrated to have better clinical outcomes compared with traditional techniques.However, it has not been compared with other assisted tools for the treatment of lumbar degenerative disease.This article focused on studying such variances.Material/methods: a total of 176 pedicle screws were inserted in 39 patients using a spine robot (group 1), 134 screws were implanted in 28 patients using navigational template (group 2), 234 screws were implanted in 51 patients by o-arm-based navigation (group 3), and 346 screws were implanted in 72 patients by fluoroscopy-guided assistance (group 4).The screw position was evaluated using postoperative scans according to rampersaud a to d classification, and other secondary data were also collected.Results: ¿perfect¿ pedicle screw insertion (grade a) was 90.34%, 91.79%, 84.19%, and 65.03% of groups 1¿4, respectively.¿clinically acceptable¿ screw implantation (grade a+b) was 94.32%, 95.52, 90.60%, and 78.03% in groups 1¿4, respectively.Deviation sagittal (°) respectively was 3±9, 2±10, 4±7, and 10±8° in groups 1¿4, respectively.Deviation transversal (°) screw insertion was 3±8, 3±7, 4±9, and 8±13° in groups 1¿4, respectively.Statistical analysis showed group 1 had no significant difference in the accuracy of ¿perfect and clinical acceptable¿ as well as deviation sagittal or transversal, respectively, compared with groups 2 and 3 but not group 4.Conclusions: robotic-assistance technology no clear advantage in terms of accuracy compared to the navigation template or o-arm systems for screw implantation, but it significantly reduced adverse events, fluoroscopy time per screw, postoperative stay, and blood loss.51 patients underwent o-arm based navigation system-assisted spinal fixation.Reported events: eight screws were revised intra-operatively.Twenty-two screws were considered grade c, pedicle cortical breach <(><<)>4 millimeters.One patient who underwent o-arm based navigation system-assisted spinal fixation had dural tears.Three patients who underwent o-arm based navigation system-assisted spinal fixation had surgical wound revision.One patient who underwent o-arm based navigation system-assisted spinal fixation had wound infection.Two patients who underwent o-arm based navigation system-assisted spinal fixation had seroma.

• Brand Name: IMAGING SYSTEM
• 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: 8946704
• MDR Text Key: 156921641
• Report Number: 3004785967-2019-01537
• Device Sequence Number: 1
• Product Code: JAA
• 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: 08/29/2019

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: 07/31/2019
• Initial Date FDA Received: 08/29/2019
• 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: 65 YR