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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Bone Fracture(s) (1870); Myocardial Infarction (1969); Nerve Damage (1979); Urinary Retention (2119)

Event Date 04/22/2016

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 a lateral lumbar interbody fusion as specific patients could not be identified.This value reflects the majority gender of the patients who underwent a lateral lumbar interbody fusion as specific patients could not be identified.The article did not provide the date of the procedure.The event date provided is the published online 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 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

Joseph, j.R., smith, b.W., patel, r.D., <(>&<)>amp; park, p.(2016).Use of 3d ct-based navigation in minimally invasive lateral lumbar interbody fusion.Journal of neurosurgery: spine, 25(3), 339¿344.Https://doi.Org/10.3171/2016.2.Spine151295.Summary: objective: lateral lumbar interbody fusion (llif) is an increasingly popular technique used to treat degenerative lumbar disease.The technique of using an intraoperative cone-beam ct (icbct) and an image-guided navigation system (igns) for llif cage placement has been previously described.However, other than a small feasibility study, there has been no clinical study evaluating its accuracy or safety.Therefore, the purpose of this study was to evaluate the accuracy and safety of image-guided spinal navigation in llif.Methods: an analysis of a prospectively acquired database was performed.Thirty-one consecutive patients were identified.Accuracy was initially determined by comparison of the planned trajectory of the igns with post¿cage placement intraoperative fluoroscopy.Accuracy was subsequently confirmed by postprocedural ct and/or radiography.Cage placement was graded based on a previously described system separating the disc space into quarters.Results: the mean patient age was 63.9 years.A total of 66 spinal levels were treated, with a mean of 2.1 levels (range 1¿4) treated per patient.Cage placement was noted to be accurate using igns in each case, as confirmed with intraoperative fluoroscopy and postoperative imaging.Sixty-four (97%) cages were placed within quarters 1 to 2 or 2 to 3, indicating placement of the cage in the anterior or middle portions of the disc space.There were no instances of misguidance by igns.There was 1 significant approach-related complication (psoas muscle abscess) that required intervention, and 8 patients with transient, mild thigh paresthesias or weakness.Conclusions: llif can be safely and accurately performed utilizing icbct and igns.Accuracy is acceptable for multilevel procedures.Reported event: thirty one patients with a histology of degenerative lumbar disease underwent a lateral lumbar interbody fusion.One patient developed a psoas muscle abscess.Two patients had a myocardial infarction, with one being a non-st-segment elevation associated with atrial fibrillation and rapid ventricular response.One patient developed the miller-fisher variant of acute with intermittent demyelinating polyneuropathy.Another patient developed urinary retention.All the above patients made a full recovery with no residual effects.One patient's procedure was aborted due to an endplate fracture that occurred during disc preparation.See attached article.

• 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
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14948216
• MDR Text Key: 295443224
• Report Number: 3004785967-2022-00445
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• 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: 06/30/2022
• Initial Date FDA Received: 07/07/2022
• 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: 64 YR
• Patient Sex: Female