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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 7510100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cyst(s) (1800)
Event Date 09/19/2011
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 consumer via manufacturing representative regarding a infuse part used spinal therapy.It was reported that patient is stating the infuse has caused him to have tumors or cysts.He had the surgery redone in 2013.He stated he has lesions and it has really changed his life.He stated he has had x-rays, ct¿s.He wants the actual data we have on infuse to see if it causes tumors or cysts.Their was no further complication reported.
 
Manufacturer Narrative
Section b5: additional information 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.
 
Event Description
The information was received from consumer via manufacturing representative regarding a infuse part used spinal therapy.It was reported that patient is stating the infuse has caused him to have tumors or cysts.He had the surgery redone in 2013.He stated he has lesions and it has really changed his life.He stated he has had x-rays, ct¿s.He wants the actual data we have on infuse to see if it causes tumors or cysts.Their was no further complication reported.Additional information received states that the patient had failed surgery on his back 10 years ago.
 
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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 Key11501275
MDR Text Key240273126
Report Number1030489-2021-00353
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
PMA/PMN Number
P000054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number7510100
Device Catalogue Number7510100
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received09/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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