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

Model Number 'MATRIX1GCC'

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2021

Event Type  Injury  

Event Description

On (b)(6) 2021 patient underwent an anterior lumbar interbody arthrodesis at l5-s1 followed by a posterior spinal fusion with instrumentation.

• Brand Name: MEDTRONIC 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: 11900992
• MDR Text Key: 253562681
• Report Number: MW5101617
• 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

• 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: 'MATRIX1GCC'
• Device Catalogue Number: VBM9910
• Device Lot Number: 'NMDS210011006'
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2021
• 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: 46 YR