Information was received, from a healthcare professional (hcp)/ attorney via a medtronic representative.Regarding a patient implanted with pedicle screws for an unknown spinal therapy.For an unknown spinal indication.It was reported, that the hcp did not abide by the standard of care relating to the selection of appropriate length and placement of those pedicle screws.In particular, the hcp deviated from the standard of care in that the screws used in patient's case were too long and were also malpositioned.The patient suffered injury and continues to suffer permanent physical injury, an elevated risk of future injury, disfigurement, disability, mental and physical pain and suffering, both in the past and in the future.No further complications were reported/ anticipated.
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D4: product identifiers are unknown.G4: 510k# is unknown, as product identifiers are not known.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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