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

Model Number	LSKB1-BX-05
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/25/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Intraoperative x-ray confirmed retained fragments.
Event or Problem 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.
Additional 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.
Additional 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."udi related data quality updates only".Updated updated 09/20/2024.Clarification and correction of the following missing items from previous supplemental report: combination product- no.Brand name- anchor bolt kit, lsb style.Model and catalog number lskb1-bx-05.Primary di number - (b)(4).
Event or Problem 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.

• 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: 18326947
• Report Number: 2183456-2023-00010
• Device Sequence Number: 7034746
• Product Code: GZL
• UDI-Device Identifier: 00841823104281
• UDI-Public: 00841823104281
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 09/20/2024

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 Model Number: LSKB1-BX-05
• Device Catalogue Number: LSBK1-BX-05
• Device Lot Number: 837838839; 825826827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/01/2023; 12/01/2023
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/02/2024; 09/20/2024
• 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