Model Number 641003050 |
Device Problem
Break (1069)
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Patient Problems
Pain (1994); Unspecified Musculoskeletal problem (4535)
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Event Type
Injury
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Event Description
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Information was received from a healthcare provider via a manufacturer representative regarding a patient with a medical history of l5/s1 lytic listhesis and l4/5 disc degeneration with l5/s1 foraminal stenosis.It was reported that the patients left s1 screw had broken.Patient felt a grating sensation.Surgeon reported that the patient has some symptoms.Patient had pain since surgery, but grating and increased pain.The screw broke post operatively, but it is uncertain when.Well after discharge.Date of surgery was the (b)(6) 2021, but it is uncertain when the screw broke.Procedure or therapy performed was l4/5/s1 decompression and pedicle screw fusion.Additional surgery is planned with no date of surgery at the moment.The patient has had their broken screw parts removed.It was discovered that the rod had broken and the right s1 screw was also broken.
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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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H3.Product analysis product id : 641003050 lot no.: 0408950w there were two rods returned both rods have broken in a similar mode.No pre-existing surface defects were identified that could contribute to the breaks.A microscopic review of the fracture surface reveals an area of crack propagation with a sheer lip on the other side of the fracture face.There did not appear to be any evidence of cyclic fatigue across the fracture face.Both the area of crack propagation and the sheer lip are in plane with the location of the set screw witness mark.The previous observations are consistent with bend stress overload.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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