Model Number MSB_UNK_SCREW |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 05/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product identifiers are unknown 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 multiple sources (manufacturer representative, healthcare provider, clinical study mdt17074sd1706) reg arding a patient with clinical id (b)(4).It was reported that interbody bone graft seen at both levels with incomplete osseous incorporation and there was loosening around pedicle screws.Surgery date: (b)(6) 2021 treatment levels name: l3-l4, l4-l5 volume of local bone autograft implanted - superior treated level: 13 cc volume of local bone autograft implanted - inferior treated level: 13 cc volume of allograft bone implanted (if needed to supplement local bone autograft) - superior treated level: 0 cc volume of allograft bone implanted (if needed to supplement local bone autograft) - inferior treated level: 0 cc total estimated blood loss: 500 ml sponsor assessment: not related to the procedure, possible related to grafting material, to the capstone peek, and to the posterior supplemental fixation system primary diagnosis: instability site related assessment : possibly related to capstone peek spinal system implant, posterior supplemental fixation system, and tlif grafting material and procedure.
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Event Description
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Update received action type: diagnostic action subtype: ct without contrast2 action result: partial fusion at l4/l5, non-union at l3/l4 action date: 2023-04-11 ct: lucency around rt l5 pedicle screw.Partial osseus fusion at l4/l5 and non-union at l3/l4.
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Manufacturer Narrative
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B5: additional info updated.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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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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Sponsor assessment result: yes comments: cec assessment possible to the procedure, to grafting material, to the capstone peek and to the posterior supplemental fixation system.
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Search Alerts/Recalls
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