MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number UNK_NAV_SYS

Device Problem Imprecision (1307)

Patient Problems Seroma (2069); Post Operative Wound Infection (2446); Unspecified Nervous System Problem (4426); Unspecified Tissue Injury (4559)

Event Date 09/12/2020

Event Type  Injury  

Manufacturer Narrative

Patient information was not included in the journal article.This value reflects the average age of the patients in the article specific patients could not be identified.This value reflects the gender of the majority of the patients in the article specific patients could not be identified.Please note that this date is based off of the date the article was published online as the event dates were not provided in the published literature.Article citation is included.System serial number not provided in journal article.Udi not available for this system.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: du j, gao l, huang d, shan l, wang w, fan y, hao d, yan l.Radiological and clinical differences between tinavi orthopedic robot and o-arm navigation system in thoracolumbar screw implantation for reconstruction of spinal stability.Med sci monit.2020 sep 12;26:e924770.Doi: 10.12659/msm.924770.Pmid: 32918810; pmcid: pmc7507796.Summary: background: pedicle screw fixation is one of the most commonly used methods in spine surgery.We introduce a surgical robot system from china based on 3-dimensional fluoroscopy imaging and compare it with the commonly used o-arm navigation system.We study the differences in accuracy, safety, and clinical effect in auxiliary pedicle screw fixation.Material/methods: patients who underwent thoracolumbar internal fixation in our hospital from 2017 to 2019 were divided into a robot and navigation group according to whether surgery was assisted by the tinavi orthopedic robot or o-arm navigation system.Imaging data of patients were searched from the image system and accuracy of screw implantation was measured by rampersaud a to d grade classification.Deviation sagittal, deviation transversal, and facet joint violation were also measured and calculated.Results: in total, 306 patients were included: 136 patients in the robot group with 760 screws implanted; 166 patients in the navigation group with 908 screws implanted.The accuracy of ¿perfect¿ and ¿clinically acceptable¿ pedicle screw implantation was 96.2% and 99.6%, respectively, in the robot group and 90.5% and 96.7%, respectively, in the navigation group, with a significant difference between the 2 groups (p<(><<)>0.05).The sagittal and transversal deviations in the robot group were significantly less than those in the navigation group (p<(> <<)>0.05).Conclusions: the tinavi orthopedic robot can significantly improve surgical accuracy and safety of pedicle screw fixation, as compared with that of o-arm navigation technology, without increasing complications.It shows great potential in clinical application.The accuracy of screw placement was evaluated according to rampersaud a to d classification as follows: grade a, the screw is completely within the pedicle; grade b, the screw penetrated the pedicle¿s cortex <(><<)>2 mm; grade c, the screw penetrated the pedicle¿s cortex <(><<)>4 mm; and grade d, the screw penetrated the pedicle¿s cortex 4 mm.Grade a is regarded as ¿perfect¿ screw implantation, grade a and b are considered as ¿clinically acceptable¿ screw placement, and grades c and d are considered ¿poor¿ screw placement positions (figure 3).Intraoperative screw revision during surgery was directly recognized as grade d.Reported events: two patients experienced neurological complications.Two patients experienced surgical wound revision.Two patients experienced post-operative revision for screw malposition.8 screws were revised intra-operatively.One patient experienced dural tears.One patient experienced wound infections.Three patients experienced seroma see attached article.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11922895
• MDR Text Key: 256458447
• Report Number: 1723170-2021-01465
• Device Sequence Number: 1
• Product Code: HAW
• 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: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2021
• 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
• Patient Age: 60 YR