Model Number 55750016540 |
Device Problem
Malposition of Device (2616)
|
Patient Problem
Paraplegia (2448)
|
Event Date 09/29/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
H3: neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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
|
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having posterior fusion at th12-l5 for pyogenic spondylitis.It was reported that after installing the iliac reference frame, oarm/navi was used to begin inserting the th12 screw. after inserting the th12 screw, a sense of discomfort was felt when creating the pilot hole for the th11 screw, so the screws were inserted into l4 and l5 vertebral bodies first, and then transferred to the th12 and th11 screws, but it was changed to a spinous process reference, and the oarm was rotated again.At that time, the screw of th12 was found to have deviated into the spinal canal and was reinserted.After that, the screw was inserted into the remaining vertebral body and the surgery was completed.Patient developed lower limb paralysis. there was a delay of less than 60 minutes in the overall procedure time.There were no further complications reported regarding the event.
|
|
Search Alerts/Recalls
|
|