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

Model Number	106130-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Pain (1994); Swelling/ Edema (4577)
Date of Event	05/01/2026
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 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.
Event or Problem Description
The sales rep reported that the patient experienced a burning pain in her buttocks after sleeping with the device last weekend.The customer service representative called the patient and found that the pads had burned her on her back.The patient stated she had pain in her buttocks.The 72r electrodes were close to each other, 3 inches apart.The patient stated she has 2 red marks on her back.She had the electrodes on for 2 or 3 days when she got the burn on may 1st.The patient stated she has pain on her buttocks.The patient went to her pcp today and got an injection for the pain.The patient stated the pain has gone away.The patient did not call the surgeon.The patient has increased her daily activities.Her foot started swelling.The pain level from the burn was a 10.The patient asked her husband to take the electrodes off.The pain in the buttocks was a 10 as well.The patient stated that she did not have this pain before.The patient cannot sleep because of the pain.The patient does not want to continue treatment.No further consequences were reported.

• 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: 25414862
• Report Number: 0002242816-2026-00072
• Device Sequence Number: 5726025
• Product Code: GXY
• UDI-Device Identifier: 00812301020201
• UDI-Public: 00812301020201
• Combination Product (Y/N): N
• 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
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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: 106130-20
• Device Catalogue Number: 106130-20
• Device Lot Number: 25H011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic