G4: please note that this device is not marketed in the united states; however, the device is deemed the same as the united states marketed device catalog # c01a, 510k # k041584, (b)(4).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.
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Information was received from a healthcare professional via a manufacturer representative regarding a patient with preoperative diag nosis for primary osteoporosis.Type of fracture compression fracture.Procedure or procedure performed was bkp.Level at which implant performed was l4.It was reported that the cement hardening was fast.Problem with bone cement.After 8 minutes of stirring, the cement became hard and difficult to insert.The hardened cement was used for approx.1cc to the patient and could not be refilled any more, so a new cement was used.There was no patient symptoms or complications as a result of this event.The overall procedure delay time was less than 60 minutes.
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