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
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.The device is used for treatment.Section a: the patient's dob is unknown.Attempts will be made to obtain the information.Section b3: the date of the event is unknown.Event occurred in 2025.
Event or Problem Description
It was reported that the patient had an allergic reaction to the cover patches.The patient wore the electrodes for few days.The patient contacted their doctor and was sent wound tape to use.It was later reported that a nurse who came to the patient¿s house ordered the tape.The patient stated that they had a strong reaction to the cover patches and developed a significant rash.The patient was prescribed hydrocortisone cream and methadone cream for the rash which took about a week to clear up.No further information was provided.
Additional Manufacturer Narrative
Additional information in h4: manufacture date, g3, h6 and h10: additional narrative.There was no date of birth for the patient, (b)(6).This follow-up report is being submitted to relay additional and corrected information.The electrode cover patches were not returned to ebi 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.
Event or Problem Description
It was reported that the patient had an allergic reaction to the cover patches.The patient wore the electrodes for few days.The patient contacted their doctor and was sent wound tape to use.It was later reported that a nurse who came to the patient¿s house ordered the tape.The patient stated that they had a strong reaction to the cover patches and developed a significant rash.The patient was prescribed hydrocortisone cream and methadone cream for the rash which took about a week to clear up.No further information was provided.Csr anamaria emailed the rep if he knew anything about the skin irritation to the cover patches.Update 16sep2025 - pss brianne mcgill called the patient to confirm who provided the wound tape to the patient.The patient stated that a nurse who came to his house had the tape ordered, stated it is a clear tape with adhesive on the edges, similar to what would be used for a wound dressing.The patient was not sure what brand the wound tape was.The patient stated that the cover patches must have had latex in them as he had a strong reaction.Stated he developed a significant rash.The patient was prescribed hydrocortisone cream and methadone cream to put on the rash.It took about a week to clear up.The patient confirmed the issue was with the covers and not the electrodes.The patient stated that his skin still becomes irritated with the wound tape, but not nearly as bad as with the cover patches.The patient changes the electrodes every 3-4 days and occasionally takes a day off to let the skin breath.Patient was advised to call back with any further issues.

• 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: 23287103
• Report Number: 0002242816-2025-00125
• Device Sequence Number: 15667125
• Product Code: LOF
• UDI-Device Identifier: 00812301020195
• UDI-Public: 00812301020195
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/12/2026

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 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: 10/15/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2024
• 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: N/A.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic