MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. LSB ANCHOR BOLT; ELECTRODE, DEPTH

Model Number LSB-AX-06

Device Problem Break (1069)

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

Event Date 02/26/2019

Event Type  malfunction  

Event Description

When inserting the anchor bolt, the bolt snapped.Part of the bolt was impaled into the cranium.A needle driver was used to secure the anchor bolt and unscrew it and remove it entirely.

• Brand Name: LSB ANCHOR BOLT
• Type of Device: ELECTRODE, DEPTH
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 w oakview pkwy; oak creek WI 53154
• MDR Report Key: 8407228
• MDR Text Key: 138355735
• Report Number: 8407228
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/08/2019,02/28/2019

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 Model Number: LSB-AX-06
• Device Catalogue Number: LSBK1-AX-06
• Device Lot Number: 0121088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7665 DA