MAUDE Adverse Event Report: NUVASIVE NUVASIVE; BOX TIP CURETTE

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2014

Event Type  malfunction  

Event Description

Add'l info received on (b)(6) 2014 for report mw5039489: nerve hook used to remove box tip curette from operative site broke at the tip.Tip was unable to be removed.Confirmed by x-ray.

Event Description

Box curette tip broke off of shaft and handle of instrument inside pt during procedure.Pt repositioned and instrument tip removed successfully.

• Brand Name: NUVASIVE
• Type of Device: BOX TIP CURETTE
• Manufacturer (Section D): NUVASIVE; paramus NJ
• MDR Report Key: 4325060
• MDR Text Key: 5240823
• Report Number: MW5039489
• Device Sequence Number: 1
• Product Code: FZS
• 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,Followup
• Report Date: 11/14/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR