MAUDE Adverse Event Report: MEDTRONIC LEGACY 6.35 SS IMPLANT SYSTEM; SPINAL SYSTEM

Model Number 7663535

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 03/25/2013

Event Type  Injury  

Event Description

Deep spine infection status post psf in (b)(6) 2011.Hardware removed.

• Brand Name: LEGACY 6.35 SS IMPLANT SYSTEM
• Type of Device: SPINAL SYSTEM
• Manufacturer (Section D): MEDTRONIC; memphis TN
• MDR Report Key: 5690766
• MDR Text Key: 46383381
• Report Number: MW5062555
• Device Sequence Number: 1
• Product Code: KWQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7663535
• Device Lot Number: 20799
• Was Device Available for Evaluation?: No
• 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): Hospitalization
• Patient Age: 19 YR