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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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| Model Number 55840006550 |
| Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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| Patient Problem
Numbness (2415)
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| Event Date 01/02/2020 |
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Event Type
malfunction
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Manufacturer Narrative
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The following screws were used in the surgery: it is unknown that which of the following screws loosened: 1.Product id: 55840006550, lot: unk, qty: 4, udi: (b)(4), 510k: k113174 2.Product id: 55840007540, lot: unk, qty: 3, udi: (b)(4), 510k: k113174 3.Product id: 55840006540, lot: unk, qty: 1, udi: (b)(4), 510k: k113174.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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Information was received from a post market study via manufacturer representative regarding a patient with clinical id: (b)(6).It was reported that patient reported numbness of left third toe and a sensation of movement in lower back on (b)(6) 2020 clinic visit with ct of (b)(6) 2020 showing l3 pedicle screw loosening and normal clinical exam on (b)(6) 2020.Next scheduled ct on (b)(6) 2020 showed no change.No mention of numbness on (b)(6) 2021 clinic visit.Onset date: (b)(6) 2020 pregnant since last visit 6_weeks: has the subject become pregnant since last visit: na.Date of visit: (b)(6) 2019.Pregnant since last visit 3_months: has the subject become pregnant since last visit: na.Date of visit: (b)(6) 2019.Pregnant since last visit 6_months: has the subject become pregnant since last visit: na.Date of visit: (b)(6) 2019.Pregnant since last visit 12_months: has the subject become pregnant since last visit: na.Date of visit: (b)(6) 2020.Pregnant since last visit 24_months: has the subject become pregnant since last visit: na.Date of visit: (b)(6) 2021.Site seriousness assessment: uade: n site related assessment: event is not related to interbody fusion and surgical procedure, it is possibly related to plf grafting material, posterior fixation device and surgical construct and/or study procedure.Sponsor assessment usade/uade assessment: n could dd have led to sade? : not applicable.Sponsor relatedness assessment: event is not related to interbody device and surgical procedure, it is possibly related to infuse kit, mgs kit and casual relationship with multiaxial screws, rods and set screws.Procedure date: (b)(6) 2019.Primary diagnostic indication all other diagnostic indications: instability (up to and including grade 2 spondylolisthesis, retrolis thesis or lateral listhesis) please indicate the number of consecutive levels (from l2- s1) the subject will have treated: 3 levels.Tobacco use ex-user outcome status: pending updated information received on 23-apr-2021: description: le pedicle screw loosening on ct.No mention of numbness or sensation of back motion on (b)(6) 2021 clinic visit.Sponsor assessment usade/uade assessment: n could dd have led to sade? : not applicable.Updated information received on 29-apr-2021: description: l3 pedicle screw loosening on ct usade/uade assessment: n could dd have led to sade? : not applicable.
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Event Description
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Updated information received on 25-may-2021: sponsor assessment: event is unlikely to be related to infuse kit, mgs kit , possibly related to multiaxial screws, rods, set screws and not related to interbody device, procedure and surgical procedure.
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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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Additional information added in b5.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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(b)(6) 2021 (b)(6) (sdy hcp rep) information was received from a post market study via manufacturer representative regarding a patient with clinical id: (b)(6).It was reported that patient reported numbness of left third toe and a sensation of movement in lower back on (b)(6) 2020 clinic visit with ct of (b)(6) 2020 showing l3 pedicle screw loosening and normal clinical exam on (b)(6) 2020.Next scheduled ct on (b)(6) 2020 showed no change.No mention of numbness on (b)(6) 2021 clinic visit.Onset date: (b)(6) 2020 pregnant since last visit 6_weeks: has the subject become pregnant since last visit: na date of visit: (b)(6) 2019 pregnant since last visit 3_months: has the subject become pregnant since last visit: na date of visit: (b)(6) 2019 pregnant since last visit 6_months: has the subject become pregnant since last visit: na date of visit: (b)(6) 2019 pregnant since last visit 12_months: has the subject become pregnant since last visit: na date of visit: (b)(6) 2020 pregnant since last visit 24_months: has the subject become pregnant since last visit: na date of visit: (b)(6) 2021 site seriousness assessment: uade: n site related assessment: event is not related to interbody fusion and surgical procedure, it is possibly related to plf grafting material, posterior fixation device and surgical construct and/or study procedure.Sponsor assessment usade/uade assessment: n could dd have led to sade? : not applicable.Sponsor relatedness assessment: event is not related to interbody device and surgical procedure, it is possibly related to infuse kit, mgs kit and casual relationship with multiaxial screws, rods and set screws.Procedure date: (b)(6) 2019 primary diagnostic indication all other diagnostic indications: instability (up to and including grade 2 spondylolisthesis, retrolis thesis or lateral listhesis) please indicate the number of consecutive levels (from l2- s1) the subject will have treated: 3 levels.Tobacco use ex-user outcome status: pending updated information received on 23-apr-2021: description: le pedicle screw loosening on ct.No mention of numbness or sensation of back motion on (b)(6) 2021 clinic visit.Sponsor assessment usade/uade assessment: n could dd have led to sade? : not applicable.Updated information received on 29-apr-2021: description: l3 pedicle screw loosening on ct usade/uade assessment: n could dd have led to sade? : not applicable.Updated information received on 25-may-2021: sponsor assessment: event is unlikely to be related to infuse kit, mgs kit , possibly related to multiaxial screws, rods, set screws and not related to interbody device, procedure and surgical procedure.Updated information received on 10-aug-2021: from (b)(4) mpxr clinical report #(b)(4) (rep): the information was received from post market study via manufacturer representative regarding a patient with clinical id: (b)(4).It was reported that the right l3 screw was loosening.Was an assessment for product/therapy/procedure relatedness made by the investigator - no was an assessment for product/therapy/procedure relatedness made by the sponsor - no was an assessment for product/therapy/procedure relatedness made by the cec - no identify the extent of the heterotopic bone formation in the right neural foramen: obstructs less than 1/3 of neural foramen identify the extent of the heterotopic bone formation in the left neural foramen: obstructs less than 1/3 of neural foramen identify the extent of the heterotopic bone formation in the spinal canal: obstructs less than 1/3 of spinal canal relevant patient medical history - hypertension, hyperlipidemia - gastroesophageal reflux disease - intermittent abdominal pain - generalized arthalgias; generalized myalgias; back pain, spondylolisthesis l5-s1; degenerative disc disease; si joint pain; degeneration l3-l5; formainal stenosis l3-s1; generalized arthritis - lumbar radiculopathy; neurogenic claudication; neuromyopathy; left leg numbness; left leg tingling - asthma - tonsillectomy; vasectomy; corneal transplant; hernia repair; epidural steroid injection; appendectomy - unspecified gait problem - intermittent dysuria - testicular pain - norco allergy - abdominal hernia (recurrence post repair); bilateral inguinal hernia (new) - primary diagnostic indication: stenosis with documented pre-operative instability - all other diagnostic indications: instability (up to and including grade 2 spondylolisthesis, retrolisthesis or lateral listhesis) - number of consecutive levels (l2-s1) the subject will have treated: 3 levels.
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Manufacturer Narrative
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Additional information added in b5.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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Updated information received on 12-jan-2022: outcome status: resolved sponsor assessment: usade/uade assessment: no could dd have led to sade? : not applicable.
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Search Alerts/Recalls
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