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

Model Number UNK_NAV_SYS

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

Patient Problem Unspecified Infection (1930)

Event Date 01/19/2022

Event Type  Injury  

Manufacturer Narrative

Patient information was not included in the journal entry.This value reflects the mean age of the patients who underwent the cervical spine procedure as specific patients could not be identified.This value reflects the majority gender of the patients who underwent the cervical spine procedure 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 system product number and serial number were not provided in the journal article.Udi not available for this system.No pma/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

Zhang, k., chen, h., chen, k., yang, p., yang, h., <(>&<)>amp; mao, h.(2022).O-arm navigated cervical pedicle screw fixation in the treatment of lower cervical fracture-dislocation.Orthopaedic surgery, 14(6), 1135¿1142.Https://doi.Org/10.1111/os.13227.Summary: objective: to evaluate the safety and efficacy of cervical pedicle screw (cps) placement with o-arm navigation in the treatment of lower cervical fracture-dislocation.Methods: a retrospective clinical study was performed involving 42 consecutivepatients with lower cervical spine fracture dislocation who underwent cps fixation surgery with o-arm navigation (cps group) or received conventional lateral mass screw (lms) fixation surgery (lms group) between august 2015 and august 2019.Accuracy of cps position was evaluated by postoperative ct.The clinical parameters including preoperative and final follow-up japanese orthopaedic association(joa) score and american spinal injury association (asia) impairment scale, preoperative sub-axial injury classification (slic) score, number of fixation segments, operation time, intraoperative blood loss, injury mechanism, injury location, surgical complications were also assessed between the two groups.Results: in lms group, the preoperative slic score was 7.5 +/- 0.9, asia score improvement was 0.8 +/- 0.5, joa score improvement was 3.0 +/- 1.8, mean operation time was 204 +/- 89 min, intraoperative blood loss was 311 +/- 127 ml.In cps group, the preoperative slic score was 7.3 +/- 1.2, asia score improvement was 0.9 +/- 0.5, joa score improvement was 3.2 +/- 2.4, mean operation time is 241 +/- 85 min, intraoperative blood loss is about 327 +/- 120 ml.There was no significant difference in terms of above clinical parameters between the two groups (p > 0.05), the fixation segments in cps group (3.5 +/- 1.1) were less than that in lms group (4.2 +/- 0.7) (p = 0.037).The accuracy of cps insertion was evaluated based on postoperative ct.Of all the 118 cpss, 83 (70.3%) were defined as grade 0; 27 (22.9%) as grade 1; eight (6.8%) as grade 2; and none as grade 3.Cps malposition rate in this study was 6.8%.In this study, there was no direct intraoperative or postoperative complication caused by cps or lms insertion.All the operations were successfully completed in two groups.One of the patients in lms group presented cerebrospinal fluid leak caused by bone fragment broken of the dural sac, which led to delayed incision healing.Cps group and lms group both had two patients who suffered pulmonary infection after surgery.A total of 78.6% of the patients showed evidence of neurologic recovery.Satisfactory reduction was achieved in all cases and maintained throughout the follow-up duration.Conclusion: in the treatment of lower cervical spine fracture-dislocation, cervical pedicle screw insertion with o-arm navigation is a safe and effective method for posterior fixation.Reported events: twenty two patients with a histology of lower cervical spine fracture-dislocation underwent a cervical spine procedure.Two patients suffered a pulmonary infection after surgery.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14943642
• MDR Text Key: 295405394
• Report Number: 1723170-2022-01036
• 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,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 06/30/2022
• 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): Other
• Patient Age: 52 YR
• Patient Sex: Male