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 Problems Hematoma (1884); Spinal Cord Injury (2432); Post Operative Wound Infection (2446); Insufficient Information (4580)

Event Date 10/26/2021

Event Type  Injury  

Manufacturer Narrative

Patient information was not included in the journal article.This value reflects the mean age of the patients in the so group as 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.Date of event: 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 serial number not provided in journal article.Udi not available for this system.Mfr site: no.510k provided as system is unknown.Device evaluated by manufacturer: no.Evaluation was performed as this event was reported in literature.Device manufacture date: device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: tan, y.; tanaka, m.; sonawane, s.; uotani, k.; oda, y.; fujiwara, y.; arataki, s.; yamauchi, t.; takigawa, t.; ito, y.Comparison of simultaneous single-position oblique lumbar interbody fusion and percutaneous pedicle screw fixation with posterior lumbar interbody fusion using o-arm navigated technique for lumbar degenerative diseases.J.Clin.Med.2021, 10, 4938.Https://doi.Org/10.3390/jcm10214938.Summary: minimally invasive posterior or transforaminal lumbar interbody fusion (mi-plif/tlif) are widely accepted procedures for lumbar instability due to degenerative or traumatic diseases.Oblique lateral interbody fusion (olif) is currently receiving considerable attention because of the reductions in damage to the back muscles and neural tissue.The aim of this study was to compare clinical and radiographic outcomes of simultaneous single-position olif and percutaneous pedicle screw (pps) fixation with mi-plif/tlif.This retrospective comparative study included 98 patients, comprising 63 patients with single-position olif (group so) and 35 patients with mi-plif/tlif (group p/t).Cases with more than 1 year of follow-up were included in this study.Mean follow-up was 32.9 ± 7.0 months for group so and 33.7 ± 7.5 months for group p/t.Clinical and radiological evaluations were performed.Comparing group so to group p/t, surgical time and blood loss were 118 versus 172 min (p < 0.01) and 139 versus 374 ml (p < 0.01), respectively.Cage height, change in disk height, and postoperative foraminal height were significantly higher in group sothan in group p/t.The fusion rate was 96.8% in group so, similar to the 94.2% in group p/t (p = 0.985).The complication rate was 6.3% in group so and 1 4.1% in group p/t (p = 0.191).Simultaneous single position o-arm-navigated olif reduces the surgical time, blood loss, and time to ambulation after surgery.Good indirect decompression can be achieved with this method.Reported event: two patients in the p/t group had hematoma requiring evacuation surgery.Two patients (one in the so group and one in the p/t group) had reoperation.Two patients in the p/t group showed dural tear.One patient in the so group had an infection at the site of the reference frame incision that was treated with dressings and anti biotics.

• 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: 13240253
• MDR Text Key: 289001210
• Report Number: 1723170-2022-00054
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• 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: 01/04/2022
• 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): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female