MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM IMAGING SYSTEM; 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 Hematoma (1884); Pain (1994); Paresis (1998); Tissue Damage (2104)

Event Date 01/12/2019

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of the patients in the study.Patient gender is the majority value of the patients in the study.Patient weight not available from the site.Event date is the accepted date of the publication.Device lot number, or serial number, unavailable.510(k) is unavailable as the product serial number was not provided.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Other relevant device(s) are: product id: unk_nav_sys, serial/lot #: unk.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: balling, horst.3d image-guided surgery for fragility fractures of the sacrum.Operative orthopädie und traumatologie 2019 31:491-502.Doi.Org/10.1007/s00064-019-00629-8.Abstract: objective.Stabilizing sacral fragility fractures without radiation exposure to the surgical team.Indications.Non-displaced or minimally displaced unilateral or bilateral transalar, transforaminal or central sacral fractures in weak and osteoporotic bone.Contraindications.Displaced or highly unstable sacral fractures.Patients under therapeutic anticoagulation.Patients needing fast track orthopedic surgery.Surgical technique.Prone position.Reference clamp installation on posterior iliac crest.Initial 3d scan of posterior pelvic ring.Image-guided virtual determination of 2¿3 interforaminal iliosacroiliac trajectories in sacral vertebrae i and ii.Lateral transgluteal mini-open approach.3d image-guided insertion of 2¿3 guide wires along planned trajectories.3d-scan for controlling guide wire positions.Virtual determination of screw lengths.Cortical drilling and cannulated screw insertion along guide wires.Radiological documentation.Follow-up.Clinical and radiological follow-up after 12 weeks, 12 and 24 months including radiographs in anteroposterior, lateral, inlet and outlet views.Results.From october 2011 until october 2016 a total of 124 sacral fracture sites (in sacral vertebrae i and ii) were treated with 120 navigated sacral screws in 52 patients (48 females, 4 males; mean age 76± 10 years, range 36¿90 years) using 3d image guidance for screw placement.Image guidance accuracy was 99.2% (119/120 screws correctly placed).Complications comprised revision surgery for subfascial hematoma evacuation (n= 1) and screw removal due to loosening after 12 weeks (n= 2).Four patients died before final follow-up.Mean pain visual analogue scale (vas) decreased from 8.9± 1.1 (presurgery value) over 3.6± 1.7 (postsurgery value) to 1.8± 1.9 (2-year followup value), mean oswestry disability index (odi) improved from 86.2± 4.9% (presurgery value) over 28.5± 9.5% (postsurgery value) to 23.3± 13.7% (2-year follow-up value).Reported events: one patient showed subfascial pelvic hematoma requiring surgical evacuation on postoperative day 9 because of painful leg paresis on the side of the surgical approach.Two patients showed evidence of screw loosening prompting removal of the screws.After removal, without re-insertion of alternative implants, there was evidence of immediate relief.

Manufacturer Narrative

H2) additional information: see b5.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that no adverse events concerning these devices were observed, nor did any adverse events mentioned within the article directly relate to medtronic products.Instruments and implants used for surgeries were from ¿depuy/synthes¿ and from ¿königsee implantate gmbh¿.

• Brand Name: O-ARM IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• MDR Report Key: 9569543
• MDR Text Key: 178750383
• Report Number: 3004785967-2020-00037
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

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
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR