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

Model Number	1067718
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/22/2025
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.
Event or Problem Description
It was reported that the patient was experiencing throbbing pain while using the orthopak device.The patient had been wearing the device 24 hours per day since (b)(6) 2025 and the pain started on (b)(6) 2025.The patient did not do any extra activities.The patient rated the pain as an 8 or 9 on a scale of 1-10.The patient is taking tylenol and awaiting a call back from their doctor.Customer service advised the patient to remove the device for a few days.It was later reported that the patient continued to treat for 8 to 10 hours per day and her pain level remained at an 8 or 9 out of 10.The patient is unable to pinpoint when the pain starts since it comes and goes.The pain is in the left shoulder where the fracture is.The patient stated that she has a follow up appointment with her orthopedic doctor on (b)(6) 2025.The patient wants to continue treating with the device.No further information was provided.
Additional Manufacturer Narrative
Additonal information: b4: date of this report, g3: date received by manufacturer: h6: evaluation codes.Corrected data: d2: common device name.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.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.
Event or Problem Description
It was reported that the patient was experiencing throbbing pain while using the orthopak device.The patient had been wearing the device 24 hours per day since (b)(6) 2025 and the pain started on (b)(6) 2025.The patient did not do any extra activities.The patient rated the pain as an 8 or 9 on a scale of 1-10.The patient is taking tylenol and awaiting a call back from their doctor.Customer service advised the patient to remove the device for a few days.It was later reported that the patient continued to treat for 8 to 10 hours per day and her pain level remained at an 8 or 9 out of 10.The patient is unable to pinpoint when the pain starts since it comes and goes.The pain is in the left shoulder where the fracture is.The patient stated that she has a follow up appointment with her orthopedic doctor on (b)(6) 2025.The patient wants to continue treating with the device.No further information was provided.

• Brand Name: BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH 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: 21677161
• Report Number: 0002242816-2025-00044
• Device Sequence Number: 8343418
• Product Code: LOF
• UDI-Device Identifier: 00812301020232
• UDI-Public: 00812301020232
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/19/2025

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
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2025
• 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: 79 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic