MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Model Number G9010001540 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 healthcare professional via field representative regarding patient with symptoms of dislocation fracture at c7 involved in posterior spinal fixation.Levels implanted- c2-t3.C7 was skipped.It was reported that during procedure, when tightening prolock, it was tried to place the product with a t-bolt positioner, but the product could not be tightened.There was a possibility of bone interference, so the bone was cut, but the product could not be tightened.The size and position were changed for dealing with it.Product was used correctly according to the directions given in the ifu/labeling.Product did not break.Patient was not hospitalized prolong and no patient symptoms/complications reported as a result of the event.No additional surgery/treatment performed as a result of this event.
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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 healthcare professional via field representative regarding patient with symptoms of dislocation fracture at c7 involved in posterior spinal fixation.Levels implanted- c2-t3.C7 was skipped.It was reported that during procedure, when tightening prolock, it was tried to place the product with a t-bolt positioner, but the product could not be tightened.There was a possibility of bone interference, so the bone was cut, but the product could not be tightened.The size and position were changed for dealing with it.Product was used correctly according to the directions given in the ifu/labeling.Product did not break.Patient was not hospitalized prolong and no patient symptoms/complications reported as a result of the event.No additional surgery/treatment performed as a result of this event.On 2021-may-07, received additional information that there was no delay in the overall procedure time.
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Manufacturer Narrative
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H3: device evaluated summary- after visual and optical examination and functional testing, it does not appear to be any damage, nor does it indicate any functional issues with the link.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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