MDT SOFAMOR DANEK PUERTO RICO MFG INFINITY¿ OCCIPITOCERVICAL UPPER THORACIC SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL
|
Back to Search Results |
|
Model Number G3600215 |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/01/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
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 an event which occurred post the o to c2 spinal fusion procedure.This was a repeat surgery since graft bone had been absorbed, so the bone was transplanted again.It was reported that the rod was detached immediately before the surgery.The misalignment of the rod was notified on an x-ray, so it was judged that the screw was loose, confirmed during the surgery.The connector was loose, the set screw of the occipital plate might be bad, or it might be misaligned due to a load.There was a delay of less than 60 mins. there was no patient symptom reported.There were no further complications reported regarding the event.
|
|
Search Alerts/Recalls
|
|
|