MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. MEDTRONICS SPINALGRAFT TECH T FIBERCELL VIABLE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Model Number MATRIX 10CC

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

Patient Problems Diarrhea (1811); Fever (1858); Nausea (1970); Swelling/ Edema (4577)

Event Date 03/28/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, patient had lumbar fusion surgery and readmitted on (b)(6) 2021 with complaints of fever, nausea, diarrhea.Ct scan revealed a fluid.

• Brand Name: MEDTRONICS SPINALGRAFT TECH T FIBERCELL VIABLE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.
• MDR Report Key: 11900978
• MDR Text Key: 253542803
• Report Number: MW5101616
• Device Sequence Number: 1
• Product Code: NEK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2023
• Device Model Number: MATRIX 10CC
• Device Catalogue Number: VBM9910
• Device Lot Number: NMDS210011011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 73 YR