MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE SURGICAL TRAY; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

Device Problems Crack (1135); Peeled/Delaminated (1454); Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 09/25/2020

Event Type  Injury  

Event Description

Our operating room staff noted small black "flecks" of an unknown substance in five separate vendor-supplied nuvasive surgical trays that were wrapped and autoclaved.The black flecks were coming from the cracking and peeling powder coating from the trays themselves.Fda safety report id# (b)(4).

• Brand Name: NUVASIVE SURGICAL TRAY
• Type of Device: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): NUVASIVE, INC.
• MDR Report Key: 10884693
• MDR Text Key: 217948604
• Report Number: MW5098017
• Device Sequence Number: 5
• Product Code: KCT
• 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: 11/18/2020
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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): Required Intervention