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

Model Number	LSBK1-BX-06
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient has not experienced any symptoms due to the broken bolt.The doctor does not plan on removing the bolt from the patient's skull.
Event or Problem Description
On wednesday (7/16) the eeg team were rewrapping the head, and the bolt was completely out and dangling on the electrode.Once they saw that the bolt was removed/broke, the patient received a ct which showed that a portion of the bolt was stuck in the skull.This was not a routine ct and a portion of the bolt is still in the patient's skull.
Additional Manufacturer Narrative
The patient has not experienced any symptoms due to the broken bolt.The doctor does not plan on removing the bolt from the patient's skull.Updated 08/06/2025 when the patient was brought back to the or to have the electrodes removed, dr.Yang was also able to remove the remnants of the broken bolt.
Event or Problem Description
On wednesday (b)(6) the eeg team were rewrapping the head, and the bolt was completely out and dangling on the electrode.Once they saw that the bolt was removed/broke, the patient received a ct which showed that a portion of the bolt was stuck in the skull.This was not a routine ct and a portion of the bolt is still in the patient's skull.

• Brand Name: ANCHOR BOLT KIT, LSB STYLE
• Common Device Name: ANCHOR BOLT KIT, LSB STYLE
• 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: 22629285
• Report Number: 2183456-2025-00006
• Device Sequence Number: 21067067
• Product Code: GZL
• UDI-Device Identifier: 00841823109538
• UDI-Public: 00841823109538
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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 Model Number: LSBK1-BX-06
• Device Catalogue Number: LSBK1-BX-06
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown