MAUDE Adverse Event Report: EBI, LLC. BIOMET ORTHOPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM; STIMULATOR, BONE GROWTH, NON-INVASIVE

Model Number	1067718
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Blister (4537); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient report that he felt a burning sensation on his skin while treating with the orthopak device.The patient stated that he found a huge burn on the skin.The patient spoke to his foot doctor and primary care physician.The primary care physician advised the patient to use an antibiotic ointment.The patient stated that he contacted the zimvie sales representative who advised him to use the 48" lead wire and to keep the controller in his pants pocket instead of the sock.The patient's skin was red, swollen and it had a blister.The skin issue was the shape of the controller from wearing it against his skin.The patient¿s attorney is in possession of the device.No additional information has been reported at this time.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The device history records are unable to be reviewed.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 followup report will be sent.
Additional Manufacturer Narrative
Corrections in b4: date of the report, b5: event description, d3: manufacturer g1: contact office, g6: type of report.Additional information in d4, g3, h4: device manufacture date, h6: component, investigation type, findings, and conclusions 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 for trend.
Event or Problem Description
The patient report that he felt a burning sensation on his skin while treating with the orthopak device.The patient stated that he found a huge burn on the skin.The patient spoke to his foot doctor and primary care physician.The primary care physician advised the patient to use an antibiotic ointment.The patient stated that he contacted the zimvie sales representative who advised him to use the 48" lead wire and to keep the controller in his pants pocket instead of the sock.The patient's skin was red, swollen and it had a blister.The skin issue was the shape of the controller from wearing it against his skin.The patient¿s attorney is in possession of the device.No additional patient consequences/ further information has been reported.The bhs controller was not returned for further evaluation.
Event or Problem Description
The patient report that he felt a burning sensation on his skin while treating with the orthopak device.The patient stated that he found a huge burn on the skin.The patient spoke to his foot doctor and primary care physician.The primary care physician advised the patient to use an antibiotic ointment.The patient stated that he contacted the zimvie sales representative who advised him to use the 48" lead wire and to keep the controller in his pants pocket instead of the sock.The patient's skin was red, swollen and it had a blister.The skin issue was the shape of the controller from wearing it against his skin.The patient¿s attorney is in possession of the device.No additional patient consequences/ further information has been reported.The orthopak controller was not returned for further evaluation.
Additional Manufacturer Narrative
Corrections in b4: date of the report, b5: event description, d1, d2a, d3: manufacturer, g1: contact office, g6: type of report.Additional information in d4, g3, h5, h6 and h10: additional narrative.Udi related data quality updates only - a supplemental report is being submitted to address the discrepancies between fda medwatch form 3500a and gudid.

• Brand Name: BIOMET ORTHOPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
• 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: 18231968
• Report Number: 0002242816-2023-00132
• Device Sequence Number: 3226190
• Product Code: LOF
• UDI-Device Identifier: 00812301020232
• UDI-Public: 00812301020232
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 09/09/2025

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 Model Number: 1067718
• Device Catalogue Number: 1067718
• 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; Not provided
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 07/23/2024; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic