MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK INC. GRAFT BONE KIT INFUSE EXTRA SMALL

Catalog Number 7510100

Device Problem Microbial Contamination of Device (2303)

Patient Problem Fungal Infection (2419)

Event Date 10/17/2022

Event Type  Injury  

Event Description

Possible contamination of allograft or allograft bone kit with aspergillus fumigatus.Patient received allograft on (b)(6) 2022.Returned to the operating room on (b)(6) 2022 for exploration of wound and wound vac placement, aspergillus found on wound culture.Patient again, returned to operating room on (b)(6) 2022 for wound cleanout, bone graft from patient's r iliac crest.Operating room, ventilation ducts and connected operating room suites underwent air testing once aspergillus was found and testing was negative.Operating room and connecting suites tested again after and again testing negative.Also checking with local facilities for possible aspergillus infections as another patient in the facility with similar surgery has aspergillus infection during the month of october.Surgery was not on same day but in same month with the same allograft devices used.

• Brand Name: GRAFT BONE KIT INFUSE EXTRA SMALL
• Type of Device: GRAFT BONE KIT INFUSE EXTRA SMALL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK INC.; minneapolis MN
• MDR Report Key: 16428491
• MDR Text Key: 310085031
• Report Number: 16428491
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510100
• Device Lot Number: MGG02010SAA1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 131 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American