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 1CC

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

Patient Problem Abscess (1690)

Event Date 04/19/2021

Event Type  Injury  

Event Description

On (b)(6) 2021 patient underwent cervical anterior discectomy and fusion with interbody cage, mba, allograft and plate, return to the or for evacuation of abscess, hardware removal, and revision of acdf on (b)(6) 2021.Afb cultures are positive.

• 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.; minneapolis MN 55432
• MDR Report Key: 11930075
• MDR Text Key: 254461638
• Report Number: MW5101694
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): Y
• 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: 06/02/2021
• 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 1CC
• Device Catalogue Number: VBM9910
• Device Lot Number: NMDS210011229
• 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: 44 YR