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

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
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.Section b3: as the day of the event is unknown, the event date is estimated as june of 2025.
Event or Problem Description
It was reported by the patient that the 72r electrodes take some skin off when she removes them.She also has issues with many band-aides and products used during the surgery.The patient does not use any creams on the irritated skin.She advised that because it hurts when removed she wears each set of electrodes for 4 days, and has 4 locations on her back when she rotates.The patient stated that each irritated spot takes about one week to heal.The patient is comfortable with this routine because she has dealt with skin issues for a long time and her focus is healing her bones.63b electrodes were shipped to the patient.Patient was advised to test the 63b electrodes on her arm before sticking them on her back.No further consequences are reported.There was no product returned for further evaluation.
Additional Manufacturer Narrative
Corrections in b4: date of the report, d2: product code.Additional information in b5, g3, h6 and h10: additional narrative.This follow-up report is being submitted to relay additional and corrected 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.Highridge medical will continue to monitor trends.
Event or Problem Description
It was reported by the patient that the 72r electrodes take some skin off when she removes them.She also has issues with many band-aides and products used during the surgery.The patient does not use any creams on the irritated skin.She advised that because it hurts when removed she wears each set of electrodes for 4 days and has 4 locations on her back when she rotates.The patient stated that each irritated spot takes about one week to heal.The patient is comfortable with this routine because she has dealt with skin issues for a long time and her focus is healing her bones.63b electrodes were shipped to the patient.Patient was advised to test the 63b electrodes on her arm before sticking them on her back.No further consequences were reported.The 72r electrodes were not returned for further evaluation.

• 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: 22338706
• Report Number: 0002242816-2025-00088
• Device Sequence Number: 18409384
• Product Code: GXY
• UDI-Device Identifier: 00812301020201
• UDI-Public: 00812301020201
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/28/2025

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: 04/29/2026
• Device Model Number: 106130-20
• Device Catalogue Number: 106120-20
• Device Lot Number: 25A110
• 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: 06/26/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2025
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic