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

Model Number	106130-20
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Skin Discoloration (2074); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: the month and day of the event are unknown.The event occurred in 2024.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 that the electrodes burnt the patient¿s skin.The electrodes felt hot on the skin, and the skin was discolored where the electrodes were placed.The skin felt irritated.The skin irritation was first noticed by the patient¿s physical therapist as the electrodes are placed on the back of her neck.The patient did not recall if she spoke to her doctor about irritation at the time of the incident.It was later reported that the patient showed pictures of the irritation to a doctor at an urgent care facility on (b)(6) 2025 and it was determined to be a burn.A replacement device and electrodes were shipped to the patient.No further consequences were reported.
Event or Problem Description
It was reported that the electrodes burnt the patient¿s skin.The electrodes felt hot on the skin, and the skin was discolored where the electrodes were placed.The skin felt irritated.The skin irritation was first noticed by the patient¿s physical therapist as the electrodes are placed on the back of her neck.The patient did not recall if she spoke to her doctor about irritation at the time of the incident.It was later reported that the patient showed pictures of the irritation to a doctor at an urgent care facility on (b)(6) 2025 and it was determined to be a burn.A replacement device and electrodes were shipped to the patient.No further consequences were reported.
Additional Manufacturer Narrative
Additional information in the following fields - b4: date of this report, g3: date received by manufacturer, h6: method, results, conclusions.Section b3: the month and day of the event are unknown.The event occurred in 2024.This follow-up report is being submitted to relay additional information.The device was 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.

• Brand Name: BIOMET SPINALPAK / ORTHOPAK
• Common Device Name: ELECTRODES 72R, SOFT TOUCH REPLACEMENT
• 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: 21437480
• Report Number: 0002242816-2025-00030
• Device Sequence Number: 4336880
• Product Code: LOF
• UDI-Device Identifier: 00812301020201
• UDI-Public: 00812301020201
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P850022/S017
• 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): 07/08/2025

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: 01/30/2025
• Device Model Number: 106130-20
• Device Catalogue Number: 106130-20
• Device Lot Number: 329340
• 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: 02/21/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2023
• 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: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic