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

Model Number	RD16R-SP03X-000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient had seeg surgery on thursday (b)(6) 2025.After explanting electrodes in the or surgically the patient was sent for a ct scan (routine procedure for the hospital).There were no issues during removal of the electrodes, they were explanted without incident.The scan revealed that a metal fragment remained in the brain.Scans prior to implant did not show that the metal fragment existed so it was assumed that this was part of the electrode.
Additional Manufacturer Narrative
Dr.(b)(6) and others did try to locate the explanted electrodes to examine for missing pieces however, they had been disposed of and they could not locate them in the garbage.The patient was fine and did not suffer any deficits so the decision was made to leave the metal fragment in the brain.The surgeon and dr.(b)(6) explained that the metal fragment may not be able to be removed from the brain as the removal could result in damage to the patient due to the location of the metal fragment.The imaging that was done prior to seeg surgery clearly showed no metal fragment existed prior.The customer was informed of our product limitations of intended temporary (29 days or less) use.The surgeon and doctor were comfortable with the decision to leave it.
Additional Manufacturer Narrative
Dr.(b)(6) and others did try to locate the explanted electrodes to examine for missing pieces however, they had been disposed of and they could not locate them in the garbage.The patient was fine and did not suffer any deficits so the decision was made to leave the metal fragment in the brain.The surgeon and dr.Boro explained that the metal fragment may not be able to be removed from the brain as the removal could result in damage to the patient due to the location of the metal fragment.The imaging that was done prior to seeg surgery clearly showed no metal fragment existed prior.The customer was informed of our product limitations of intended temporary (29 days or less) use.The surgeon and doctor were comfortable with the decision to leave it.Updated 03/14/2025: the post op scans showed a metal remnant that was not there in the pre op scan.The scans provided by the hospital confirm the complaint.The electrodes were discarded and they were unable to confirm the electrodes complete.Without confirmation of the source of the metal fragment, no root cause can be identified.There are no corrective actions.
Event or Problem Description
Patient had seeg surgery on thursday (b)(6) 2025.After explanting electrodes in the or surgically the patient was sent for a ct scan (routine procedure for the hospital).There were no issues during removal of the electrodes, they were explanted without incident.The scan revealed that a metal fragment remained in the brain.Scans prior to implant did not show that the metal fragment existed so it was assumed that this was part of the electrode.

• Brand Name: DEPTH ELECTRODE
• Common Device Name: 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: 21282549
• Report Number: 2183456-2025-00001
• Device Sequence Number: 18471442
• Product Code: GZL
• UDI-Device Identifier: 00841823109026
• UDI-Public: 00841823109026
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K223269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 03/14/2025

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
• Operator of Device: Health Professional
• Device Model Number: RD16R-SP03X-000
• Device Catalogue Number: RD16R-SP03X-000
• Device Lot Number: 888889890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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