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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EATONTOWN GRAFTON DBM BONE GRAFTING MATERIAL, HUMAN SOURCE

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MEDTRONIC EATONTOWN GRAFTON DBM BONE GRAFTING MATERIAL, HUMAN SOURCE Back to Search Results
Catalog Number T44115INT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Date 02/16/2019
Event Type  Injury  
Manufacturer Narrative
Manufacturing assessment review: five manufacturing records were reviewed and no related deviations or non conformances were observed for the batch a36012 and part# t44115. Grafton crunch test reports were reviewed (base sterility, sterility, endotoxin, moisture analysis, glycerol content, calcium assay). All tests passed and no deviations or non conformances were observed. Donor file - donor eligibility records: donor eligibility documents were reviewed and no non-conformance was found. The donor charts revealed-no deviations from sop, supplies were in compliance and recovery was performed in time and temperature limits. Hcps reviews based on donor charts: in their opinion the infections weren¿t caused by tissues as received, processed and distributed by us. 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. Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient underwent scoliosis correction surgery from t6 to s1. Post-op, one month later the implantation of the tissues, the patient suffered due to infection in wound. Patient immune was not compromised and she was not undergoing chemotherapy. Patient went through 24 hour prophylaxis protocol after the initial surgery. The symptoms appeared 10 days after the initial surgery because 10 days later when they were going to remove the stitches, the patient indicated that the wound was open. Patient suffered due to fever as well approx 3 weeks after the initial surgery. Patient underwent revision surgery, where the implants were extracted and a sample have been sent to the laboratory to determine if the infection was caused by the implants. As per the latest update, patient was still in the hospital (icu). Doctors performed another washing of the wound site because the wound was getting infected. At the wound site, doctors found a bacterium called "large negative germ¿. Also in the blood culture they found a staphyloco ccus. They did an echocardiogram and it came out negative. The doctor states that it is not certain that the graft is the initial cause of the event.
 
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Brand NameGRAFTON DBM
Type of DeviceBONE GRAFTING MATERIAL, HUMAN SOURCE
Manufacturer (Section D)
MEDTRONIC EATONTOWN
201 industrial way west
eatontown NJ 07724
Manufacturer (Section G)
MEDTRONIC EATONTOWN
201 industrial way west
eatontown NJ 07724
Manufacturer Contact
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key8419789
MDR Text Key138767949
Report Number2246640-2019-00002
Device Sequence Number1
Product Code NUN
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K051188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2021
Device Catalogue NumberT44115INT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/14/2019 Patient Sequence Number: 1
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