|
Catalog Number 55711016540 |
Device Problem
Failure to Align (2522)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/18/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
This part is not approved for use in the united states; however a like device catalog # 55811016540, 510k # k122433 and udi # (b)(4) was cleared in the united states.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.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that the patient underwent fixation at t12-l1 due to lordosis and fracture at t12.Intra-op, after placing the rod, when the set screw was inserted into the screw at l1, it did not thread into the screw head.This action was performed three times and the same issue occurred with all the set screws.Finally, the screw was replaced by another screw and the procedure was completed successfully.No patient complications were reported due to this event.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
H6: product analysis: after visual and optical examination and functional testing, it does not appear to be any damage nor does it indicate any functional issues with the screw.There was no fault found.Additional information: d10, h3, h6 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
|
|
|