MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK / ORTHOPAK; Electrode, Cutaneous

Model Number	106130-20
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); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a validconclusion 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.Section b3: as the day of the event is unknown, the event date is estimated as march of 2026.
Event or Problem Description
The patient reported that the 72r electrodes irritated their skin.The patient stated that she developed a rash with open sores while using the 72r electrodes.The patient changed them daily and rotated the position on her skin.The patient wears them on her neck.The patient stated that she spoke to her doctor, who suggested that she continue wearing the unit and apply cortisone cream to the area.The patient is seeing her doctor again on 03/23 and will call back with an update.The patient was advised to take a break in treatment until her skin is completely healed.Patient will conduct a time test with the 63b electrodes.No further consequences were reported.The 72r electrodes were not returned for further evaluation.
Event or Problem Description
It was later reported that the patient continued to have skin irritation.The patient spoke with the prescribing doctor and a dermatologist who said that not only are the 72r 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 stated that the electrodes caused a rash and seemed to burn her 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¿s doctor ultimately decided to prescribe an alternative device due to the patient¿s ongoing skin irritation.No further information was provided.
Additional Manufacturer Narrative
Additional information: b2: outcomes attributed to adverse event, b4: date of this report, g3: date received by manufacturer, h6: patient code, device code, impact code corrected data: d4: lot number and expiration date, h4: device manufacture date, h6: component code, method code.This follow-up report is being submitted to relay additional and corrected information.

• 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 ; +1(973)299-9300
• MDR Report Key: 24660835
• Report Number: 0002242816-2026-00038
• Device Sequence Number: 5054823
• Product Code: GXY
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2026

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: Other
• Device Model Number: 106130-20
• Device Catalogue Number: 106130-20
• Device Lot Number: 25L008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 09/10/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 06/16/2026; 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Unknown