MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
|
Back to Search Results |
|
Model Number UNK_OARM_SYS |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Data Problem (3196)
|
Patient Problems
Inflammation (1932); Unspecified Tissue Injury (4559)
|
Event Date 06/08/2022 |
Event Type
Injury
|
Event Description
|
Citation: https:/ /doi.Org/10.1007 /s00402-022-04514-1.Summary: introduction in spinal surgery, precise instrumentation is essential.This study aims to evaluate the accuracy of navigated, o-arm-controlled screw positioning in thoracic and lumbar spine instabilities.Materials and methods posterior instrumentation procedures between 2010 and 2015 were retrospectively analyzed.Pedicle screws were placed using 3d rotational fluoroscopy and neuronavigation.Accuracy of screw placement was assessed using a 6-grade scoring system.In addition, screw length was analyzed in relation to the vertebral body diameter.Intra- and postoperative revision rates were recorded.Results thoracic and lumbar spine surgery was performed in 285 patients.Of 1704 pedicle screws, 1621 (95.1 %) showed excellent positioning in 3d rotational fluoroscopy imaging.The lateral rim of either pedicle or vertebral body was protruded in 25 (1.5%) and 28 screws (1.6%), while the midline of the vertebral body was crossed in 8 screws (0.5%).Furthermore, 11 screws each(0.6%) fulfilled the criteria of full lateral and medial displacement.The median relative screw length was 92.6%.Intraoperative revision resulted in excellent positioning in 58 of71 screws.Follow-up surgery due to missed primary malposition had to be performed for two screws in the same patient.Postsurgical symptom relief was reported in 82.L % of patients, whereas neurological deterioration occurred in 8.9% of cases with neurological follow-up.Conclusions combination of neuronavigation and 3d rotational fluoroscopy control ensures excellent accuracy in pedicle screw positioning.As misplaced screws can be detected reliably and revised intraoperatively, repeated surgery for screw malposition is rarely required.Reported events: this was a retrospective study of 285 patients and the placement of 1704 pedicle screws.134 were women, and the mean patient age at the time of surgery was 64.1 +/- 12.6 years.25 screws (1.5%) protruded the lateral rim of the pedicle.28 screws (1.6%) protruded the lateral margin of the vertebral body.8 screws (0.5%) crossed the vertebra's midline.There were 11 screws (.6%) that were fully displaced laterally or medially.Repeated surgery was necessary in 11 patients, with a total of 40 screws (2.3%) being repositioned.2 screws (0.1%) in one patient had to berevised due to primary malposition.20 screws (1.2%) had to be revised due to progressive loosening.15 screws (0/9%) had to be revised due to connection instability.3 screws (0.2%) had to be revised due to inflammation-induced remodeling.
|
|
Manufacturer Narrative
|
G2: this event occurred in germany.H3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.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.
|
|
Search Alerts/Recalls
|
|
|