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

Model Number	CEDL-3PDINX-100
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 09-03-2024 ad-tech was made aware of an impedance test that was consistently too high while using spinal electrodes.The surgeon adjusted the position several times and the result was still the same.There was no patient harm or injury reported.However, it was reported that there was a significant delay during the procedure.
Additional Manufacturer Narrative
Upon initial review of the complaint reportability that was completed on 9/23/2024, it was determined that this issue would not be reported.At this time, the complaints team had not received the communication checklist back from the customer yet.On 10/7/2024, the communication checklist was received and it was stated that there was a significant delay (1.5 hours) during the procedure.The customer stated that there was no patient impact, but as a conservative measure, a decision was made to report this issue.
Additional Manufacturer Narrative
Upon initial review of the complaint reportability that was completed on 9/23/2024, it was determined that this issue would not be reported at this time.The complaints team had not received the communication checklist back from the customer yet.On 10/7/2024, the communication checklist was received and it was stated that there was a significant delay (1.5 hours) during the procedure.The customer stated that there was no patient impact, but as a conservative measure, a decision was made to report this issue.Updated 11-6-2024.The product was returned to ad-tech for evaluation.The electrode's three (3) contacts during electrical testing showed erratic readings, thus confirming the complaint.Therefore, the loss of signal is being evaluated against the process fmea since the deficiency is a result of the process and testing of the electrode and not a result of the use or design of the product.As the issue occurred in all three contacts, the most likely area of impact is the connection between the electrode body and the attached cable.While no definitive root cause could be determine, a small tug on this location would be enough to affect the signal in all contacts.There are no corrective actions.
Event or Problem Description
On 09-03-2024 ad-tech was made aware of an impedance test that was consistently too high while using spinal electrodes.The surgeon adjusted the position several times and the result was still the same.There was no patient harm or injury reported.However, it was reported that there was a significant delay during the procedure.

• Brand Name: SPINAL ELECTRODE
• Common Device Name: SPINAL 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: 20537397
• Report Number: 2183456-2024-00010
• Device Sequence Number: 15146798
• Product Code: JXE
• UDI-Device Identifier: 00841823100801
• UDI-Public: 00841823100801
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K973454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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
• Operator of Device: Health Professional
• Device Model Number: CEDL-3PDINX-100
• Device Catalogue Number: CEDL-3PDINX-100
• Device Lot Number: 864865866 171159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2023
• 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
• Patient Sex: Unknown