MEDTRONIC SOFAMOR DANEK USA, INC T2 STRATOSPHERE¿ EXPANDABLE CORPECTOMY SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
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Model Number 436013A |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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Information was received from health care professional via manufacturing representative regarding a patient undergoing unknown spine surgery.It was reported that implant wind up teeth broken during expansion of device.No issue with endcap being attached to implant.No patient symptoms associated with this event.No further complications were reported/anticipated due to this event.Additional information was received from the rep that procedure used in this event was c5 corpectomy, pre op diagnosis details of this event was previous infection in c5 vertebrae.Procedure was extended by 20 minutes due to this event.
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Manufacturer Narrative
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H3: product analysis #705718011:part # 436013a: lot # ca18m002 visual and optical inspection of the centerpiece expander did not reveal any damages that would hinder the implant from expanding.Optical inspection revealed a few of the gears/teeth has been damaged and deformed.Functional inspection with a sample 13mm inserter confirmed the implant was able to connect and engage, expand and close without any grinding or restrictions.The implant body set screw may have been partially locked down causing the teeth/gears to be stripped during the attempted expansion process.D4: lot number updated.H4 <(>&<)> h6: updated with additional information available.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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