MAUDE Adverse Event Report: EBI, LLC. Biomet SpinalPak / OrthoPak; Electrode, Cutaneous

Model Number	106130-22
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 that the patient experienced skin irritation with the 63b electrodes.The patient stated that she thinks she let her skin heal prior to using the electrodes.The patient only wore the electrodes for a little while, not all day.The patient discontinued use of the bone growth stimulator due to the skin irritation issue and will be prescribed a different unit.No further consequences were reported.
Additional Manufacturer Narrative
Section b3: as the date of onset for the skin irritation is unknown.The event date is estimated as (b)(6) 2026.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.

• 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: 50227787
• Report Number: 0002242816-2026-00094
• Device Sequence Number: 16040652
• Product Code: GXY
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 08/12/2026

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: 608401
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female