MAUDE Adverse Event Report: NUVASIVE CORONET; CORONET XL WIDE INSERTER

Model Number CORONET XL WIDE INSERTER

Device Problems Device Reprocessing Problem (1091); Contamination /Decontamination Problem (2895)

Patient Problem No Information (3190)

Event Date 11/13/2015

Event Type  malfunction  

Event Description

Nuvasive inserter (b)(4) cannot be properly cleaned, decontaminated, and sterilized for safe patient use because the components of the surgical instrument cannot be disassembled for proper cleaning inside the lumen/cannulated area of the device.

• Brand Name: CORONET
• Type of Device: CORONET XL WIDE INSERTER
• Manufacturer (Section D): NUVASIVE; san diego CA 62121
• MDR Report Key: 5236517
• MDR Text Key: 31678671
• Report Number: MW5057955
• Device Sequence Number: 1
• Product Code: MAX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CORONET XL WIDE INSERTER
• Device Catalogue Number: 6900401
• Was Device Available for Evaluation?: Yes
• 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): Other