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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Model Number TLIFIDE420
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Numbness (2415)
Event Date 08/28/2020
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
The information was received from a clinical study with clinical patient id: (b)(6), via a manufacturing representative regarding a patient for spinal therapy.It was reported that patient called the clinic on (b)(6) 2020 complaining of left buttock pain that has begun to radiate below the knee.He also has a burning sensation of the right leg with continued numbness.The severity is considered moderate.His lyrica dosage was changed from 75 mg bid to 100 mg tid and to continue taking 2 tabs percocet q4 hours and robaxin 1000 mg tid.He was also instructed to do stretches of his legs/hamstrings and increase walking.Medical history: hypertension, blurred vision, gastroesophageal reflux disease, heartburn, elevated alanine aminotransferase, elevated aspartate aminotransferase, anterolisthesis of l5-s1, bilateral neuroforaminal stenosis, broad based disc herniation at the lumbar 5 sacral 1, central canal stenosis, central disc herniation at lumbar 4 5, discogenic disease at l5-s1, impingement of the spinal canal, isolated discogenic disease at l-5s1, left buttock pain, left lower extremity radiculopathy, lower back pain, weakness of plantar flexion of the left foot, change in stream, stones, testicular pain, arthroscopic surgery of the right hip, dupuytren's contracture of the left hand, left elbow, deep vein thrombosis right lower extremity, primary diagnosis: stenosis.Additional surgery : surgery date: (b)(6) 2020 spinal surgeon last name: cress treatment levels name: l5-s1 was the procedure navigated: y was a mazor robot used during the procedure: n surgical access: minimally invasive (i.E.Metrx or quadrant) side of capstone insertion - superior treated level: left soak time for the rhbmp-2 onto the acs prior to implantation - superior treated level: 33 minutes volume of local bone autograft implanted - superior treated level: 1 cc volume of allograft bone implanted (if needed to supplement local bone autograft) - superior treated level: 10 cc total estimated blood loss: 50 ml was an intra-wound antibiotic (iwa) used: n was the subjects interbody space preparation and graft placement completed as instructed per the surgical checklist: y interventions : action subtype: ae result in hospitalization action result: n action subtype: any other action(s) taken action result: n action subtype: did the ae result in any treatment action result: y action subtype: drug therapy action result: yes action subtype: home exercise action result: yes action subtype: physical therapy; action result: yes outcome status not recovered/not resolved diagnostics action type: diagnostic action subtype: were any diagnostic test performed action result: n site seriousness assessment: congenital anomaly, death, disability, hospitalization, life threatening.Medical intervention are not present.Severity of ae : moderate.Site related assessment: this event was not related to any devices and causal relationship with surgical procedure used.Sponsor assessment: result: yes comments: medtronic assessed ae related to the tlif grafting material as possible relation.
 
Manufacturer Narrative
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.
 
Event Description
The information was received from a clinical study with clinical patient id: (b)(6), via a manufacturing representative regarding a patient for spinal therapy.It was reported that patient has continued left buttock pain that has now radiated below the knee.Medical history: hypertension, blurred vision, gastroesophageal reflux disease, heartburn, elevated alanine aminotransferase, elevated aspartate aminotransferase, anterolisthesis of l5-s1, bilateral neuroforaminal stenosis, broad based disc herniation at the lumbar 5 sacral 1, central canal stenosis, central disc herniation at lumbar 4 5, discogenic disease at l5-s1, impingement of the spinal canal, isolated discogenic disease at l-5s1, left buttock pain, left lower extremity radiculopathy, lower back pain, weakness of plantar flexion of the left foot, change in stream, stones, testicular pain, arthroscopic surgery of the right hip, dupuytren's contracture of the left hand, left elbow, deep vein thrombosis right lower extremity, primary diagnosis: stenosis.Additional surgery : surgery date: (b)(6) 2020 spinal surgeon last name: cress treatment levels name: l5-s1 was the procedure navigated: y was a mazor robot used during the procedure: n surgical access: minimally invasive (i.E.Metrx or quadrant) side of capstone insertion - superior treated level: left soak time for the rhbmp-2 onto the acs prior to implantation - superior treated level: 33 minutes volume of local bone autograft implanted - superior treated level: 1 cc volume of allograft bone implanted (if needed to supplement local bone autograft) - superior treated level: 10 cc total estimated blood loss: 50 ml was an intra-wound antibiotic (iwa) used: n was the subjects interbody space preparation and graft placement completed as instructed per the surgical checklist: y interventions : action subtype: ae result in hospitalization action result: n action subtype: any other action(s) taken action result: n action subtype: did the ae result in any treatment action result: y action subtype: drug therapy action result: yes action subtype: home exercise action result: yes outcome status not recovered/not resolved diagnostics action type: diagnostic action subtype: were any diagnostic test performed action result: n site seriousness assessment: congenital anomaly, death, disability, hospitalization, life threatening.Medical intervention are not present.Severity of ae : moderate.Site related assessment: this event was not related to any devices and causal relationship with surgical procedure used.Sponsor assessment: result: yes comments: medtronic assessed ae related to the tlif grafting material as possible relation.Additional information states that interventions: action subtype: physical therapy; action result: yes additional information states that patient called the clinic on (b)(6) 2020 complaining of left buttock pain that has begun to radiate below the knee.He also has a burning sensation of the right leg with continued numbness.The severity is considered moderate.His lyrica dosage was changed from 75 mg bid to 100 mg tid and to continue taking 2 tabs percocet q4 hours and robaxin 1000 mg tid.He was also instructed to do stretches of his legs/hamstrings and increase walking.Additional information received states that outcome status recovered/resolved.Outcome date (b)(6) 2021.
 
Manufacturer Narrative
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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Brand Name
INFUSE BONE GRAFT
Type of Device
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
MDR Report Key10558944
MDR Text Key207706836
Report Number1030489-2020-01320
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
PMA/PMN Number
P000058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,study
Type of Report Initial,Followup,Followup
Report Date 03/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2021
Device Model NumberTLIFIDE420
Device Catalogue NumberTLIFIDE420
Device Lot NumberMAN2076AAX
Was Device Available for Evaluation? No
Date Manufacturer Received02/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age44 YR
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