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

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 a31336 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 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.

• Brand Name: GRAFTON DBM
• Type of Device: BONE 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 Key: 8419792
• MDR Text Key: 138768931
• Report Number: 2246640-2019-00004
• Device Sequence Number: 1
• Product Code: NUN
• UDI-Device Identifier: 00643169134324
• UDI-Public: 00643169134324
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K051188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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 Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2021
• Device Catalogue Number: T44115INT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 55 YR