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

Model Number	106130-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rash (2033); Blister (4537); 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 september of 2025.
Event or Problem Description
It was reported by the patient that the 72r electrodes caused a skin irritation.It was a rash that was red with blisters and was very itchy.The patient used benadryl and hydrocortisone cream to apply over the affected area.The patient was not sure if this had been prescribed previously.The patient stated he is not sure if his wife contacted the doctor regarding the skin irritation.The patient will start using the 63b electrodes once their skin has healed from the rash.No further consequences are reported.There was no product returned for further evaluation.
Event or Problem Description
It was reported by the patient that the 72r electrodes caused a skin irritation.It was a rash that was red with blisters and was very itchy.The patient used benadryl and hydrocortisone cream to apply over the affected area.The patient was not sure if this had been prescribed previously.The patient stated he is not sure if his wife contacted the doctor regarding the skin irritation.The patient will start using the 63b electrodes once their skin has healed from the rash.No further consequences are reported.There was no product returned for further evaluation.
Additional Manufacturer Narrative
Corrections in b4: date of the report, d2: type of device.Additional information in d2b, g1, 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 from the customer.The device history record was reviewed, and no discrepancies related to the reported event were found.The root cause could not 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
• 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: 23351924
• Report Number: 0002242816-2025-00126
• Device Sequence Number: 13044335
• Product Code: GXY
• UDI-Device Identifier: 00812301020201
• UDI-Public: 00812301020201
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/27/2026

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 Model Number: 106130-20
• Device Catalogue Number: 106120-20
• Device Lot Number: 25C020
• 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: 10/21/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 67 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic