MAUDE Adverse Event Report: MEDTRONIC MEDICAL COSTA RICA S.R.L. ROD 5.5 MM CCM LINED 500MM-SN/IA ORTHOPEDIC SPINAL ROD IMPLANT SOLERA; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 1555200500

Device Problem Use of Device Problem (1670)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Date 02/13/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, patient underwent a t2-pelvis posterior instrumented spinal fusion with possible temporary internal distraction, ponte osteotomies, bone graft substitute, locally collected autograft, and use of spinal navigation, halo ring removal.Patient had cefepime pre and post procedure.On (b)(6) 2023, patient spiked a fever of 101 and infectious disease was consulted.Returned to operating room on 3/1/2023 for aspiration of spinal fluid since crp remained elevated with fevers.Aspergillus was resulted on (b)(6) 2023.Days post procedure to ssi: 16.Prolonged hospitalization resulted due to infection.

• Brand Name: ROD 5.5 MM CCM LINED 500MM-SN/IA ORTHOPEDIC SPINAL ROD IMPLANT SOLERA
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDTRONIC MEDICAL COSTA RICA S.R.L.
• MDR Report Key: 16630936
• MDR Text Key: 312306317
• Report Number: MW5116046
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• 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: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: 1555200500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 42 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White