MAUDE Adverse Event Report: DIXI MEDICAL ANCHOR BOLT; ELECTRODE, DEPTH

Catalog Number ACS-025SMS-10

Device Problems Inadequate or Insufficient Training (1643); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 03/23/2021

Event Type  Injury  

Event Description

The anchor bolt was being inserted into the skull when the bolt threads didn't catch and advanced into the patients brain.Physician was able to retrieve the anchor bolt and an intra-operative ct was performed.Concern expressed that training and education was inadequate.

• Brand Name: ANCHOR BOLT
• Type of Device: ELECTRODE, DEPTH
• Manufacturer (Section D): DIXI MEDICAL; 11910 fox ridge drive; plymouth MI 48170
• MDR Report Key: 11744439
• MDR Text Key: 247940599
• Report Number: 11744439
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ACS-025SMS-10
• Device Lot Number: 203868-26/20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 14235 DA
• Patient Weight: 78