MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. SPENCER PROBE DEPTH ELECTRODE

Model Number	SD08R-SP05X-000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, during a procedure at a healthcare facility, one depth electrode ceased recording.Troubleshooting was performed, and it was determined that the electrode required replacement.During attempted removal, significant resistance was encountered and the electrode could not be withdrawn.An adjacent electrode was removed to rule out potential interference; however, resistance persisted.During continued removal attempts, the electrode fractured, leaving the distal portion with all eight contacts retained within the patient.A surgical burr hole was created to facilitate access and removal of the retained components.The fragmented electrode section and an associated portion of the anchor bolt tip were successfully retrieved.Post-event assessment suggested that the anchor bolt may have been damaged during drilling, resulting in structural compromise that contributed to electrode damage and fracture during removal.
Additional Manufacturer Narrative
One sd08r-sp05x-000 depth electrode and associated anchor bolt were returned for evaluation in a biohazard bag.The electrode was identified as gray 64.Visual inspection revealed that the electrode was fractured proximal to contact #8 on the brain end.Contact #8 exhibited visible deformation and damage consistent with mechanical stress.Examination of the returned anchor bolt revealed mechanical failure, with the brain-end portion of the bolt found to be severed.The condition of the anchor bolt is consistent with the application of external mechanical forces.According to the information provided by dr.(b)(6), after all fragments of the electrode and anchor bolt were removed, it was determined that the anchor bolt had likely been struck during drilling, resulting in bolt fracture.The damaged bolt subsequently contacted and cut the electrode, which ultimately led to electrode breakage during device removal.The observed damage to the returned electrode and anchor bolt is consistent with this reported sequence of events.Based on the returned product evaluation and the information received from the user facility, the complaint was confirmed.The investigation concluded that damage to the anchor bolt, likely resulting from drilling-related mechanical impact, was the probable cause of the electrode damage and subsequent electrode fracture during removal.All device components associated with the event, including both pieces of the fractured electrode, the broken fixation bolt, and a small fragment of the bolt removed from the patient, were successfully retrieved and retained.

• Brand Name: SPENCER PROBE DEPTH ELECTRODE
• Common Device Name: SPENCER PROBE DEPTH ELECTRODE
• 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: 25607974
• Report Number: 2183456-2026-00001
• Device Sequence Number: 20184779
• Product Code: GZL
• UDI-Device Identifier: 00841823109286
• UDI-Public: 00841823109286
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K223269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: SD08R-SP05X-000
• Device Catalogue Number: SD08R-SP05X-000
• Device Lot Number: 936937938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2026
• 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