MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) MEDTRONIC NAVIGATION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number UNK_OARM_SYS

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

Patient Problems Muscle Weakness (1967); Pain (1994); Spinal Column Injury (2081); Numbness (2415); Cognitive Changes (2551)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

Patient age is average age of patients in the single position lif-pps treatment group for the article.Patient gender is the majority gender of patients in the single position lif-pps treatment group for the article.Patient race for 100% of the patients in the single position lif-pps treatment group was documented in the article as asian.Please note that this date is based off of the date the article was published as the specific 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: ouchida, jun, et al.¿simultaneous single-position lateral interbody fusion and percutaneous pedicle screw fixation using o-arm-based navigation reduces the occupancy time of the operating room.¿ european spine journal, vol.29, 01 apr.2020, pp.1277-1286, https: //doi.Org/10.1007/s00586-020-06388-6 abstract: purpose: lateral interbody fusion and posterior percutaneous pedicle screw (lif-pps) fixation has been performed in two-stage positioning.The aim of this study was to investigate the surgical outcomes of simultaneous single-position lif-pps fixation using o-arm-based navigation.Methods: overall, 102 consecutive subjects underwent indirect decompression surgery for spondylolisthesis with lif-pps fixation.Fif ty-one subjects underwent surgery with repositioning, and 51 in the right lateral decubitus position.We compared these two groups in terms of the surgery time, occupancy time in the operating room, intraoperative blood loss, japanese orthopaedic association (joa) score, local lordosis acquisition in postoperative radiographs, and accuracy of screw insertion using postoperative ct scans.Results: in the single-position group, surgery time, occupancy time of the operating room, and estimated blood loss were 93.3±19.3 min (vs.The repositioning group: 121.0±37.1 min; p<(><<)> 0.001), 176.3±36.4 min (vs.272.4±42.7 min; p<(><<)>0.001), and 93.4±78.8 ml (vs.40.9±28.7 ml; p<(><<)>0.001), respectively.The joa scores (pre-/postoperative) were 15.1±3.0/24.4±2.8 (p<(><<)>0.001) for the single-position group and 15.1±4.0/24.8±3.0 (p<(><<)>0.001) for the repositioning group.The rate of misplacement was 1.8% versus 4.0%, respectively (p=0.267), and the lordosis acquisition was 4.2°±4.1° versus 4.4°±3.2°, respectively (p=0.516).Conclusions: single-position surgery exhibited comparable clinical outcomes and local lordosis acquisition with conventional repositioning lif-pps fixation.This single-position minimally invasive technique reduces the occupancy time of the operating room and workforce requirements.O-arm based navigation was used in both single position and repositioning lif-pps fixation surgical procedures.Pps misplacement was defined as pps breaching > 2 millimeters breach increments.Reported events: 1.In the single position lif-pps treatment group, endplate injury was found in 6 out of 63 segments.Transient ipsilateral muscle weakness was observed in 7 patients with complete recovery reported in all cases by the time of an outpatient visit 3 months after surgery.Post-operatively, thigh pain and numbness on the approaching side occurred in 15 patients.At 6 months after surgery, thigh numbness was reported by one patient.Transient delirium after surgery was reported in 2 subjects in the single position treatment group.There were no serious adverse events observed during hospitalization.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• 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: 10143747
• MDR Text Key: 195520476
• Report Number: 3004785967-2020-00662
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2020

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: 05/30/2020
• Initial Date FDA Received: 06/11/2020
• 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: 71 YR