MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. ANCHOR BOLT; ANCHOR BOLT, PRODUCT CODE: GZL

Catalog Number LSBK1-CX-05

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/18/2022

Event Type  malfunction  

Manufacturer Narrative

Complaintant reported that the anchor bolt broke at the threads while removing it from the patient's skull.The doctor stated that the fragment would be left in the patient and would not be removing it at this time.The doctor also inquired what the anchor bolt material was, which ad-tech confirmed is titanium.There was report of any patient impact or harm, and no product lot number or batch number has been received yet by the user facility.The anchor bolt has not yet been returned.

Event Description

During explant of electrodes, an anchor bolt broke at the threads in the patient skull.Dr.Ahmed stated that the fragment would be left in the patient and not be removed at the time of electrode explantation.There was no report of patient harm or negative impact to the patient.

Event Description

During explant of electrodes, an anchor bolt broke at the threads in the patient skull.Dr.Ahmed stated that the fragment would be left in the patient and not be removed at the time of electrode explantation.There was no report of patient harm or negative impact to the patient.

Manufacturer Narrative

Complainant reported that the anchor bolt broke at the threads while removing it from the patient's skull.The doctor stated that the fragment would be left in the patient and would not be removing it at this time.The doctor also inquired what the anchor bolt material was, which ad-tech confirmed is titanium.There was report of any patient impact or harm, and no product lot number or batch number has been received yet by the user facility.The anchor bolt has not yet been returned.(b)(6) several attempts were made to follow-up with the doctor about the removal of the anchor bolt from the patient's skull.There has been no confirmation in regards to removal of the anchor bolt.There has been no further report of patient harm or injury.Ad-tech informed the doctor that the anchor bolts intended duration of use is 30 days.

• Brand Name: ANCHOR BOLT
• Type of Device: ANCHOR BOLT, PRODUCT CODE: GZL
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• Manufacturer (Section G): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• Manufacturer Contact: monique-elise alamina ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 15805005
• MDR Text Key: 306326774
• Report Number: 2183456-2022-00020
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

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
• Device Catalogue Number: LSBK1-CX-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other