MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. LSB STYLE ANCHOR BOLT; LSB STYLE ANCHOR BOLTS

Catalog Number LSBK1-BX-05

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/25/2023

Event Type  malfunction  

Event Description

Patient was undergoing removal of electrode bolts when two of these fractured during removal, requiring additonal operative maneuvers (incision, partial skull thickness bone removal) to achieve complete device extraction under the same anesthetic.

Manufacturer Narrative

Intraoperative x-ray confirmed retained fragments.

Event Description

Patient was undergoing removal of electrode bolts when two of these fractured during removal, requiring additional operative maneuvers (incision, partial skull thickness bone removal) to achieve complete device extraction under the same anesthetic.

Manufacturer Narrative

Intraoperative x-ray confirmed retained fragments.---updated 01-02-2024---- the product was returned for evaluation.The alleged complaint was confirmed that the anchor bolt was broken.The anchor bolt broke at the point it was designed to break.Breaking can occur from many things like excessive force when tightening, patient movement (seizures) during monitoring, etc.In this case, the bolts broke at removal but we are not able to determine when the damage leading to the break occurred.The calculated occurrence level matches the occurrence level present in the risk file and the resulting risk level will remain "alap".No further action is needed at this time.

• Brand Name: LSB STYLE ANCHOR BOLT
• Type of Device: LSB STYLE ANCHOR BOLTS
• 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: 18326947
• MDR Text Key: 330548962
• Report Number: 2183456-2023-00010
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): Y
• 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: 01/02/2024

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?: No
• Device Catalogue Number: LSBK1-BX-05
• Device Lot Number: 837838839/825826827
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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