Model Number MSB_UNK_SCREW |
Device Problem
Malposition of Device (2616)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/11/2017 |
Event Type
malfunction
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Manufacturer Narrative
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H6: 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.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 clinical study, healthcare provider via manufacturer representative regarding an event happened during post-op of the reported screw.It was reported that, suboptimal pedicle screw fixation (part of the screw being extra-pedicular).Suboptimal screws are not causing any neurological compression.Possible related to minimally invasive procedure.No additional treatment or surgery performed as a result.Investigator assessment states, possible related to minimally invasive procedure.Sponsor assessment states, not related to procedure and reported device.Patient underwent three level surgery, not study surgery.Patient was enrolled on the same day, and exited the study.No further complications reported. .
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Search Alerts/Recalls
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