GRAFTON DBM T44115INT NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-14 for GRAFTON DBM T44115INT NA manufactured by Medtronic Eatontown.

Event Text Entries

[138772962] 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. Hcp's reviews based on donor charts: in their opinion the infections weren? T caused by tissues as received, processed and distributed by us. Event problem and evaluation codes: 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.
Patient Sequence No: 1, Text Type: N, H10


[138772963] 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 staphylococcus. 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2246640-2019-00003
MDR Report Key8419790
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-03-14
Date of Report2019-03-14
Date of Event2019-02-16
Date Mfgr Received2019-02-20
Device Manufacturer Date2018-11-01
Date Added to Maude2019-03-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTACIE ZIEMBA
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal38132
Manufacturer Phone9013963133
Manufacturer G1MEDTRONIC EATONTOWN
Manufacturer Street201 INDUSTRIAL WAY WEST
Manufacturer CityEATONTOWN NJ 07724
Manufacturer CountryUS
Manufacturer Postal Code07724
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGRAFTON DBM
Generic NameBONE GRAFTING MATERIAL, HUMAN SOURCE
Product CodeNUN
Date Received2019-03-14
Model NumberT44115INT
Catalog NumberNA
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC EATONTOWN
Manufacturer Address201 INDUSTRIAL WAY WEST EATONTOWN NJ 07724 US 07724


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-03-14

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