MAUDE Adverse Event Report: TEDAN SURGICAL INNOVATION LLC PHANTOM XL INSULATED DILATORS; NEUROSUGICAL NERVE LOCATOR

Model Number ML-0441S

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 07/31/2019

Event Type  malfunction  

Event Description

Pt in surgery on (b)(6) 2019, first stage of 2 part surgical spine procedure.Dilator tip broke in l3-4 disc space.Surgeon attempted to retrieve tip but was not able to.Pt was already scheduled for second procedure (b)(6) 2019.Surgeon completed second surgery on (b)(6) 2019 and was able to retrieve broken dilator tip.

• Brand Name: PHANTOM XL INSULATED DILATORS
• Type of Device: NEUROSUGICAL NERVE LOCATOR
• Manufacturer (Section D): TEDAN SURGICAL INNOVATION LLC
• MDR Report Key: 8901668
• MDR Text Key: 154765149
• Report Number: MW5089090
• Device Sequence Number: 1
• Product Code: PDQ
• Combination Product (y/n): N
• 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: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: ML-0441S
• Device Catalogue Number: ML-0441S
• Device Lot Number: 2019020501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2019
• 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 Age: 70 YR
• Patient Weight: 106