MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK / ORTHOPAK SOFT TOUCH ELECTRODES 72R; ELECTRODE, CUTANEOUS

Model Number	106130-20
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Rash (2033); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient that the 72r electrodes caused rash that look a like skin was burnt.The patient stated that she changed them daily and rotates the position on her skin.The electrodes were placed on her neck.The patient does have sensitive skin.The patient spoke with her doctor and he suggested she uses cream on area and advised patient to take a break in treatment until her skin is completely healed then conduct a time test starting with 63b electrodes.The customer service representative discussed changing the electrodes and position of electrodes each day as well as advised her to call back with any issues during the time test.No further consequences were reported.72r electrodes were not returned for evaluation.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The device history records are reviewed and no discrepancies were found.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 the 72r electrodes caused rash that look a like skin was burnt.The patient stated that she changed them daily and rotates the position on her skin.The electrodes were placed on her neck.The patient does have sensitive skin.The patient spoke with her doctor and he suggested she uses cream on area and advised patient to take a break in treatment until her skin is completely healed then conduct a time test starting with 63b electrodes.The customer service representative discussed changing the electrodes and position of electrodes each day as well as advised her to call back with any issues during the time test.No further consequences were reported.72r electrodes were not returned for evaluation.
Additional Manufacturer Narrative
Corrections in b4: date of the report, d3, g1, additional information in h6, and h10: additional narrative.This follow-up report is being submitted to relay additional and corrected information.The device was not returned for evaluation.The reported event could not 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.The 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 that would change or alter any conclusions or information, a supplemental report will be filed accordingly.

• Brand Name: BIOMET SPINALPAK / ORTHOPAK SOFT TOUCH ELECTRODES 72R
• 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: 22878198
• Report Number: 0002242816-2025-00099
• Device Sequence Number: 13368178
• 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): 01/12/2026

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: Other
• Device Expiration Date: 07/30/2026
• Device Model Number: 106130-20
• Device Lot Number: 25D017
• 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: 08/22/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2025
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic