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Model Number UNK_NAV_SYS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Thrombosis/Thrombus (4440)
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Event Date 12/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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G2: this event occurred in japan, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.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.
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Event Description
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Citation: https://doi.Org/10.1016/j.Otsr.2022.103528 summary: background: unstable pelvic fractures, especially vertical shear fractures, require surgery for correct reduction, rigid fixation, and improved postoperative outcomes.Herein, we assess the effectiveness of our minimally invasive procedure for the management of unstable pelvic fractures.Hypothesis: we hypothesized that this procedure would be useful for the management of unstable pelvic fractures.Patients methods: this study included 28 patients with unstable pelvic fractures (vertical shear injuries; ao types c1¿3) treated using minimally invasive surgery for spinopelvic fixation (mis-sp) between 2014 and 2020 (mean follow-up time, 15 months).The mis-sp requires four percutaneous pedicle screws and four iliac screw insertions.Subsequently, reduction and fixation are performed.Results: the mean preoperative displacement of the posterior pelvic elements in craniocaudal correction was 17.6 (range, 9.0¿32.2) mm.The mean length of the craniocaudal reduction was 16.5 (8.1¿30.1) mm, with a mean reduction rate of 93.5% (78%¿100%).The mean length of the mediolateral reduction was 11.3 (3.9¿19.6) mm, with a mean reduction rate of 87.3% (76%¿100%).Discussion: our novel reduction and fixation procedure is a powerful, minimally invasive option for the treatment of unstable pelvic ring fractures.Reported event(s): this article reviewed case data for 28 patients.There were 16 men and 12 women.The mean age was 40 years.There was one case of superficial infection that was recovered with intravenous antibiotics.
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Event Description
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It was reported that of the adverse events mentioned in the article, none were directly related to the medtronic device.
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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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Manufacturer Narrative
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H2: regulatory report # 1723170-2023-02766 is a duplicate of this report.Please refer to this report (1723170-2023-02785) for all future updates regarding this 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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Search Alerts/Recalls
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