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Model Number C01A-J |
Device Problems
Clumping in Device or Device Ingredient (1095); Improper Chemical Reaction (2952)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This part is not approved for use in the united states; however a like device catalog # c01a, 510k # k041584, udi # (b)(4) was cleared in the united states.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 the healthcare professional (hcp) regarding an event which occurred during a spinal kyphoplasty procedure in a patient diagnosed with primary osteoporosis (burst fracture).It was reported that after mixing the cement with the mixer for 30 seconds, the cement was lumpy so it was continued to mix the cement for more 30 seconds, and the cement was still lumpy, so it was continued to mix for more 30 seconds.But still, the cement was not doughy and homogenous, the cement was inserted into bfd for the time being, but it hardened after 4 minutes.Since the cement was in a state that could not be inserted into bfd. a new mixer and cement were opened and procedure was performed again.The new products had been used without problems.The mixer itself has no malfunction.There was delay of less than 60 mins in the overall procedure.The cement did not come in contact with the patient.No patient injury / complication was reported.
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Manufacturer Narrative
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H3: product analysis: part # c01a-j, lot # el70196 visual inspection confirmed the cement has been mixed and dried up in the mixer tube.Unable to determine viscosity of cement during use.H6: codes updated.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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Search Alerts/Recalls
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