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 Problems Wound Dehiscence (1154); Seroma (2069)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

Donor file, donor eligibility records: no additional reports of adverse events for this donor was found.Recovery of the subject donor tissue was found to be performed using a method appropriate to controlling contamination.There were no deviations from established procedures that may have increased the risk of contamination/cross contamination.All supplies and reagents used during the recovery were in compliance to the sops.The recovery was performed within the established time and temperature limits for recovery.Hcps reviews based on donor charts: this sounds like wound dehiscence, and this complication would not be caused by our product.It is a complication related to surgical wound closure.Product was not 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 a surgery at l2-l4 due to trauma.She was implanted with screws at l2, l3, l4 and a 15cc crunch.The alleged product was placed by posterolateral approach.On (b)(6) 2019, post-op, the patient returned to doctor as the back wound did not close completely and a serious secretion was observed in the wound.The patient did not have a fever, had a culture test and was negative, had no symptoms and no infection.Hence, the patient underwent an additional surgery, in which the doctor washed the wound and closed it again.

• 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: 9316513
• MDR Text Key: 167952383
• Report Number: 2246640-2019-00009
• Device Sequence Number: 1
• Product Code: NUN
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2022
• Device Catalogue Number: T44115INT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2019
• 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): Required Intervention