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

Model Number	RD14R-SP05X-000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During explant one electrode broke and remained within the patient's brain requiring an additional procedure to remove it completely.Post op ct and xr confirmed the fragment after the first attempt of explantation.A successful complete extraction of the remnant electrode was confirmed by another ct and xr after the second explant.There were no visible radio graphic injuries or neurologic deficits after the explant.
Event or Problem Description
During explant one electrode broke and remained within the patient's brain requiring an additional procedure to remove it completely.Post op ct and xr confirmed the fragment after the first attempt of explantation.A successful complete extraction of the remnant electrode was confirmed by another ct and xr after the second explant.There were no visible radio graphic injuries or neurologic deficits after the explant.
Additional Manufacturer Narrative
The product was returned for evaluation, however only the half left as remnant in the patient was returned.For the evaluation, the product underwent a visual examination to try to determine root cause.During the exam, it was found the electrode showed signs of twisting, kinking and was split in half.The complaint had been confirmed and an investigation showed a potential root cause is the electrode may have been caught on the skull or bottom of the anchor bolt thus causing the electrode to stretch and pull.Therefore, the damage to healthy tissue is being evaluated against the use fmea since the deficiency is a result of the use of the electrode and not a result of the process or testing of the electrode.The risk file matches the risk file present in the preliminary risk assessment.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.

• Brand Name: SPENCER PROBE 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: 21942636
• Report Number: 2183456-2025-00004
• Device Sequence Number: 9055940
• Product Code: GZL
• UDI-Device Identifier: 00841823109019
• UDI-Public: 841823109019
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K223269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: RD14R-SP05X-000
• Device Catalogue Number: RD14R-SP05X-000
• Device Lot Number: 903904905
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/29/2025
• 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; Required Intervention
• Patient Sex: Unknown