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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC MASTERGRAFT MATRIX EXT; FILLER, BONE VOID, CALCIUM COMPOUND
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MEDTRONIC SOFAMOR DANEK USA, INC MASTERGRAFT MATRIX EXT; FILLER, BONE VOID, CALCIUM COMPOUND Back to Search Results
Model Number 7610305
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 07/20/2020
Event Type  Injury  
Manufacturer Narrative
Post-op infection.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
Information was received from a health care professional via manufacturer representative regarding a patient who underwent corpectomy, cervical decompression.Pre-operative diagnosis for this procedure spinal stenosis; cervical compression fx.It was reported that the matrix was implanted on (b)(6) 2020 ,the placement of the product was in cage, disc space.Post operation on (b)(6) 2020 an infection was indicated per blood work.Negative results per culture taken for aerobic and anaerobic organisms and fungi.Clean out was performed around the corpectomy device.No further complications reported.
 
Manufacturer Narrative
Intervention required is added in b2.B2: other-infection.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.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
Information was received from a health care professional via manufacturer representative regarding a patient who underwent corpectomy, cervical decompression.Pre-operative diagnosis for this procedure spinal stenosis; cervical compression fx.It was reported that the matrix was implanted on (b)(6) 2020 ,the placement of the product was in cage, disc space.Post operation on (b)(6) 2020 an infection was indicated per blood work.Negative results per culture taken for aerobic and anaerobic organisms and fungi.Clean out was performed around the corpectomy device.No further complications reported.
 
Event Description
Information was received from a health care professional via manufacturer representative regarding a patient who underwent corpectom y, cervical decompression.Pre-operative diagnosis for this procedure spinal stenosis; cervical compression fx.It was reported that the matrix was implanted on (b)(6) 2020 ,the placement of the product was in cage, disc space.Post operation on (b)(6) 2020 an infection was indicated per blood work.Negative results per culture taken for aerobic and anaerobic organisms and fungi.Clean out was performed around the corpectomy device.No further complications reported.
 
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
MASTERGRAFT MATRIX EXT
Type of Device
FILLER, BONE VOID, CALCIUM COMPOUND
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
MDR Report Key10647167
MDR Text Key210415811
Report Number1030489-2020-01394
Device Sequence Number1
Product Code MQV
UDI-Device Identifier00643169322349
UDI-Public00643169322349
Combination Product (y/n)N
PMA/PMN Number
K130335
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2022
Device Model Number7610305
Device Catalogue Number7610305
Device Lot NumberCCCN19E35
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/21/2020
Initial Date FDA Received10/08/2020
Supplement Dates Manufacturer Received09/21/2020
09/21/2020
Supplement Dates FDA Received11/10/2020
11/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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