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 Insufficient Information (3190)

Patient Problems Abscess (1690); Bacterial Infection (1735)

Event Date 04/05/2021

Event Type  Injury  

Event Description

Pt underwent adcf c6-c7 with interbody spacer bma allograft on (b)(6) 2021.On (b)(6) 2021 return to the operating room for exploration and irrigation debridement anterior cervical with hardware removal and revision at c6 and c7 with instrument removal.Evacuation of epidural abscess allograft bone.Afb culture revealed a positive result of mycobacterium tuberculosis in surgical specimens and also in sputum sample.

• 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: 11912549
• MDR Text Key: 253810648
• Report Number: MW5101627
• 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: 'NMDS210011257'
• Is the Reporter a Health Professional?: Yes
• 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: 50 YR