MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK / ORTHOPAK; ELECTRODE, CUTANEOUS

Model Number	106130-22
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Rash (2033); Skin Discoloration (2074)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: as the date of the event is unknown, the event date is estimated as march of 2026 without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow up report will be sent.The device is used for treatment.Ebi will continue to monitor trends.
Event or Problem Description
It reported that the 63b electrodes caused a rash and seemed to burn the patient¿s skin.The patient claimed she could feel the electric current running through the wires and felt a burn like fire on her neck when she treated.The patient advised that she had skin issues and paused treatment for her skin to heal from time to time.The dermatologist gave her 2.5% hydrocortisone cream to heal the skin between treatments but advised the issue would not fully heal unless she stopped treating.The patient advised she never performed a time test when switching from one electrode to the next.She treated 24 hours per day, 7 days per week until march.The patient saw the surgeon in late march, and the surgeon recommended treating as much as the patient can tolerate.The patient spoke with the prescribing doctor and a dermatologist who said that not only are the 63b electrodes causing a severe reaction, but it is also the electrical current that is causing her skin to burn and become discolored and extremely sore.The patient¿s doctor ultimately decided to prescribe an alternative device due to the patient¿s ongoing skin irritation.No further information was provided.

• Brand Name: BIOMET SPINALPAK / ORTHOPAK
• Common Device Name: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 25517545
• Report Number: 0002242816-2026-00074
• Device Sequence Number: 10164703
• Product Code: GXY
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P850022
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 106130-22
• Device Catalogue Number: 106130-22
• Device Lot Number: 514601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic