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

Catalog Number LSBK1-BX-05

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

According to customer checklist; the surgeon was using the new medtronic robot, the surgeon places the bolts through the reducing sleeve on the robot, versus removing the sleeve as some do.

Event Description

On (b)(6) 2024 two anchor bolts broke off during a seeg surgical procedure.The surgeon was required to drill around the site (location of the anchor bolt) to increase the size of the hole to remove the bolt and its smaller pieces.There was no patient harm or injury reported.

Manufacturer Narrative

According to customer checklist; the surgeon was using the new medtronic robot, the surgeon places the bolts through the reducing sleeve on the robot, versus removing the sleeve as some do.Updated 03/08/2024.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.

Event Description

On (b)(6) 2024 two anchor bolts broke off during a seeg surgical procedure.The surgeon was required to drill around the site (location of the anchor bolt) to increase the size of the hole to remove the bolt and its smaller pieces.There was no patient harm or injury reported.

• 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: 18660337
• MDR Text Key: 334783251
• Report Number: 2183456-2024-00003
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

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?: Yes
• Device Catalogue Number: LSBK1-BX-05
• Device Lot Number: 819820821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 01/15/2024
• Supplement Dates FDA Received: 03/08/2024
• 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