MAUDE Adverse Event Report: MEDTRONIC EATONTOWN GRAFTON DBM; FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)

Catalog Number T44150INT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930); Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

Other: infection.Manufacturing assessment review: grafton orthoblend test reports were reviewed (base sterility, final product sterility, endotoxin, moisture analysis, glycerol content, calcium assay, environmental monitoring).All tests passed.Donor file & donor eligibility records: donor eligibility documents were reviewed and no non-conformance was found.No reports of adverse reactions involving any other orga ns/tissues recovered from this donor.Recovery of the donor tissue was performed using a method appropriate to controlling contamination.(b)(6) reviews based on donor charts: in their opinion, the graft was not the source of the patient¿s infection.They agree with the update received from the surgeon that poor oral hygiene of the mouth by the patient was the cause of the patient¿s 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.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 presented with maxillary cyst; and underwent resection and curettage of benign upper jaw injury and maxillary bone biopsy.The graft was placed on the upper jaw.Allegedly, on an unknown date, post-op, the patient had an infection at the treated site.The symptoms of the infection included fever, inflammation of the area and expulsion of liquid through the wound in the oral mucosa.Antibiotic treatment was carried out due to this event.According to the surgeon, the infection was caused by poor oral hygiene of the patient.Hence, it was recommended to wash the area with oral antiseptic to decrease symptoms and signs of infection.

• Brand Name: GRAFTON DBM
• Type of Device: FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)
• 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: 10196836
• MDR Text Key: 201080608
• Report Number: 2246640-2020-00003
• Device Sequence Number: 1
• Product Code: MBP
• UDI-Device Identifier: 00643169965089
• UDI-Public: 00643169965089
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K051195
• 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: 06/25/2020

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 Date: 08/11/2021
• Device Catalogue Number: T44150INT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/12/2019
• 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): Other
• Patient Age: 48 YR