MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK / ORTHOPAK ELECTRODES 72R, SOFT TOUCH; 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
Additional Manufacturer Narrative
Section b3: as the day of the event is unknown, the event date is estimated as march, 2025.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.
Event or Problem Description
It was reported by the patient that he is having reaction to 72r electrodes and had to go to dermatologist.Later, (b)(6) called the patient for details had to leave a voicemail for a return call.No further consequences were reported.The 72r electrodes were not returned for further evaluation.
Event or Problem Description
It was reported by the patient that he is having reaction to 72r electrodes and had to go to dermatologist.Later, cs called the patient for details had to leave a voicemail for a return call.Later patient called back and indicated that the patient experienced skin irritation, developed a rash and skin became raw/ irritated.Patient stated that the skin irritation went away as the patient stopped using the unit.The patient spoke to the prescribing physician and were advised discontinue the use of device as patient was healing well.No medications were prescribed for skin irritation.No further consequences were reported.The 72r electrodes were not returned for further evaluation.
Additional Manufacturer Narrative
Corrections in b4: date of the report, d1: brand name, d2a: device common name.Additional information in b5: event description, g3, h6 and h10: additional narrative.This follow-up report is being submitted to relay additional and corrected information.The 72r electrodes were not returned to highridge medical 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.Highridge medical will continue to monitor trends.

• Brand Name: BIOMET SPINALPAK / ORTHOPAK ELECTRODES 72R, SOFT TOUCH
• 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: 21708546
• Report Number: 0002242816-2025-00050
• Device Sequence Number: 19997525
• Product Code: GXY
• UDI-Device Identifier: 00812301020201
• UDI-Public: 00812301020201
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/28/2025

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: 06/30/2026
• Device Model Number: 106130-20
• Device Catalogue Number: 106130-20
• Device Lot Number: 409644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2024
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic