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

Model Number MATRIX 1CC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 03/29/2021

Event Type  Injury  

Event Description

On (b)(6) 2021 patient underwent an acdf c7-11 with interbody cage, bma allograft and spinal implant removal.On (b)(6) 2021, returned to the operating room for adcf revision, hardware removal partial corpectomy, irrigation and debridement.Afb cultures are positive and pending confirmation of mtb.

• Brand Name: MEDTRONIC SPINAL GRAFT 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: 11912633
• MDR Text Key: 253766519
• Report Number: MW5101629
• 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: 05/28/2021
• 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: NMDS210011224
• 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: 53 YR