MEDTRONIC SOFAMOR DANEK USA, INC.; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Device Problem
Break (1069)
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Patient Problems
Pain (1994); Paralysis (1997); Stenosis (2263); Injury (2348); Disability (2371); Unspecified Tissue Injury (4559)
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Event Type
Injury
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Manufacturer Narrative
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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.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported by the patient that he underwent surgeries on (b)(6) 2005, in 2008 and in 2012.It is unknown when he was implanted with the alleged screws.Post-operatively, the screws broke due to which he suffered from pain.As per patient, he had brain damaged and mental health issue.Reportedly, the patient had been disabled since 2019.Allegedly, he was told that the implanted screws were broken and fusion failed with stenosis.He stated that his back was like a ¿jig-saw-puzzle¿ and that "the screws broke his back in half".
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Manufacturer Narrative
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D6: only year valid correction: information about implant date corrected in b5, d6.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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It was reported that in 2008, the patient underwent l4-l5 fusion with a peek device and screws.On an unknown date in 2012, post-op, the patient was told that the screws were broken.
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Manufacturer Narrative
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B5.Updated the event description.Updated the additional codes (imf <(>&<)> img).H6.Updated the codes.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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Patient had left with a peak cage <(>&<)> lanx fixation device broken in his spine.Patient is paralyzed.
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Search Alerts/Recalls
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