MAUDE Adverse Event Report: PMT CORP. PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT; ELECTRODE, DEPTH

Patient Problems Laceration(s) (1946); Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

(b)(6) (cc) reported that there were issues with a third-party company's seeg bolts (pmt).The surgeon had placed three of the exact same leads in different areas on the patient without issue.On the fourth bolt, the bolt pushed through the patient's skull and into the brain after being placed.The same 2.4 mm drill stop was used for all bolts.The surgeon had to do a craniotomy to retrieve the lost component.The surgeon was able to successfully place the remaining bolts without issue.Surgeon does not believe the issue was related to the stealth or navigation.2-hour delay.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT
• Type of Device: ELECTRODE, DEPTH
• Manufacturer (Section D): PMT CORP.
• MDR Report Key: 18175166
• MDR Text Key: 328697794
• Report Number: MW5148321
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/15/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2023
• Patient Sequence Number: 1