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

Catalog Number	T44150INT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Inflammation (1932)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)
• Manufacturer (Section D): MEDTRONIC EATONTOWN; 201 industrial way west; eatontown NJ 07724
• MDR Report Key: 10196836
• Report Number: 2246640-2020-00003
• Device Sequence Number: 11615135
• Product Code: MBP
• UDI-Device Identifier: 00643169965089
• UDI-Public: 00643169965089
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K051195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2021
• Device Catalogue Number: T44150INT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR