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

Model Number	106130-20
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the sales representative that the patient experienced skin irritation from the opak electrodes.The doctor wants to switch the patient to bhs unit.The patient was given opak on (b)(6) 2025.The patient has sensitive skin.She treated with the unit for 2 weeks and had red, itchy and irritated skin with raised bumps with puss when they popped.She used only 72r electrodes and treated for 12 hrs a day.Changed electrodes daily, rotated the position and washed the skin with antibacterial soap and treated the irritation with hydrocortisone cream.The patient had follow-up with doctor on week 03 of treatment and told her to stop using the opak and he would like to switch her rx to bhs.The doctor did not prescribe anything for skin irritation.
Additional Manufacturer Narrative
Section b3: the event date is estimated as may of 2025 as the day of the event is unknown.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.
Additional Manufacturer Narrative
Section b3: the event date is estimated as may of 2025 as the day of the event is unknown.Additional information: b4: date of this report, d4: lot number and expiration date, g3: date received by manufacturer, h4: device manufacture date, h6: evaluation codes.Corrected data: d2: common device name and product code, e: initial reporter also sent report to fda: unknown, h6: impact code.This follow-up report is being submitted to relay additional and corrected information.The device was not returned to ebi for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record was reviewed, and no discrepancies related to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.The device is used for treatment.
Event or Problem Description
It was reported by the sales representative that the patient experienced skin irritation from the opak electrodes.The doctor wants to switch the patient to bhs unit.The patient was given opak on (b)(6) 2025.The patient has sensitive skin.She treated with the unit for 2 weeks and had red, itchy and irritated skin with raised bumps with puss when they popped.She used only 72r electrodes and treated for 12hrs a day.Changed electrodes daily, rotated the position and washed the skin with antibacterial soap and treated the irritation with hydrocortisone cream.The patient had follow-up with doctor on week 03 of treatment and told her to stop using the opak and he would like to switch her rx to bhs.The doctor did not prescribe anything for skin irritation.

• 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: 22318958
• Report Number: 0002242816-2025-00086
• Device Sequence Number: 15656496
• Product Code: GXY
• UDI-Device Identifier: 00812301020201
• UDI-Public: 00812301020201
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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,Followup
• Report Date (Section B): 10/19/2025

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 Expiration Date: 04/29/2026
• Device Model Number: 106130-20
• Device Lot Number: 25A110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic