MEDTRONIC SOFAMOR DANEK USA, INC KYPHX® HV-R¿ BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY
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Model Number C01A |
Device Problem
Leak/Splash (1354)
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Patient Problem
Extravasation (1842)
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Event Date 06/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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Information was received from health care professional via a manufacturer representative regarding bone cement used for spinal surgery.Pre-operative diagnosis was primary osteoporosis.Fracture reported was compression fracture.Procedure performed was kyphoplasty.Levels implanted was l1.It was reported that intra-operatively, while using the second bfd on the left side of the vertebral body, a cement leak was confirmed on the posterior wall.Cement filling was stopped when the leak was confirmed.There was overflow noted during operation.The cement doughy and homogenous prior to delivery into the patient.Cement was mixed for 30 seconds.The cement came in contact with patient.There were no patient symptoms or complications as a result of this event.There was no in-patient hospitalization or prolongation of existing hospitalization necessary.There was no treatment or additional surgery performed as a result of this event.There was no delay in overall procedure time.
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Manufacturer Narrative
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Correction-d4.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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