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

Model Number	LSBK1-AX-05
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient did not incur any type of injury due to this event.
Event or Problem Description
On (b)(6) 2024, two days post implantation it was discovered that the anchor bolts and electrodes were damaged due to patient seizures and combative behavior.One anchor bolt was bent and the other one broken off into 2 pieces.This caused both electrodes to be damaged.The patient required additional surgery for the removal of the broken anchor bolt and replacement of the electrodes.
Additional Manufacturer Narrative
The patient did not incur any type of injury due to this event.Updated 12/10/2024: the customer clarified our devices were not at fault but rather the violent seizures and "combative nature" of the patient damaged the bolts.The root cause has been identified as the patient movement (violent seizures, combative behavior) that led to the breaking of the bolts.There are no corrective actions at this time.
Event or Problem Description
On 11/8/2024 , two days post implantation it was discovered that the anchor bolts and electrodes were damaged due to patient seizures and combative behavior.One anchor bolt was bent and the other one broken off into 2 pieces.This caused both electrodes to be damaged.The patient required additional surgery for the removal of the broken anchor bolt and replacement of the electrodes.

• 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: 20834260
• Report Number: 2183456-2024-00011
• Device Sequence Number: 11728217
• Product Code: GZL
• UDI-Device Identifier: 00841823104267
• UDI-Public: 841823104267
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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 Expiration Date: 08/01/2026
• Device Model Number: LSBK1-AX-05
• Device Catalogue Number: LSBK1-AX-05
• Device Lot Number: 888889890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• 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