MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK / ORTHOPAK; STIMULATOR, BONE GROWTH, NON-INVASIVE

Model Number	106130-17
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Rash (2033); 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 july of 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.Related manufacturer's report: mfr# 0002242816-2025-00100.
Event or Problem Description
It was reported that the patient developed skin irritation while using the 72r electrodes and cover patches.The patient¿s skin was red and itchy with red bumps.On some days, there are hives surrounding the irritated area as well.The patient uses each set of electrodes for approximately one week and uses the cover patches for three days each.The patient was unsure if the irritation was from the electrodes, cover patches, or both.The patient spoke with her doctor who suggested over the counter hydrocortisone cream and allergy cream to fight the irritation.The patient added that she cannot rotate the position of the electrodes and cover patches because there is not much room.The patient was advised by customer service to eliminate the cover patches from her routine and perform the time test with the alternate electrodes.No further information was provided.
Event or Problem Description
It was reported that the patient developed skin irritation while using the 72r electrodes and cover patches.The patient¿s skin was red and itchy with red bumps.On some days, there are hives surrounding the irritated area as well.The patient uses each set of electrodes for approximately one week and uses the cover patches for three days each.The patient was unsure if the irritation was from the electrodes, cover patches, or both.The patient spoke with her doctor who suggested over the counter hydrocortisone cream and allergy cream to fight the irritation.The patient added that she cannot rotate the position of the electrodes and cover patches because there is not much room.The patient was advised by customer service to eliminate the cover patches from her routine and perform the time test with the alternate electrodes.No further information was provided.
Additional Manufacturer Narrative
Additional information: b4: date of this report, h2, h11.Corrected data: d3: email address, d4: expiration date, g1: email address.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.Multiple attempts were made for additional information and product return, however, neither were provided.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.Ebi will continue to monitor for trends.Related manufacturer's report: 0002242816-2025-00100.

• Brand Name: BIOMET SPINALPAK / ORTHOPAK
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE
• 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: 22879046
• Report Number: 0002242816-2025-00101
• Device Sequence Number: 17565138
• Product Code: LOF
• UDI-Device Identifier: 00812301020195
• UDI-Public: 00812301020195
• 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): 01/21/2026

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: 03/20/2026
• Device Model Number: 106130-17
• Device Catalogue Number: 106130-17
• Device Lot Number: 24D051
• 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: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic