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)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per sales rep email, hi can you guys call the patient and instruct her to build her wear time? she just got the unit.Ill apply when i get home today.See message below from the doctor office.Hi, i had patient message me this afternoon with the following: "hello, so dr (b)(6) ordered a bone stimulator.I finally got it 2 days ago on monday.I was instructed to wear it 24/7.Ive noticed that my ankle has been in alot more pain since wearing it.The lady did say that i shouldn't feel anything.So, im not sure what's going on.Is there anyway you can talk to dr (b)(6) and let her know to see what i should do.Should i keep wearing it, or should i stop? it's just been in so much more pain ever since i've started wearing it., please let me know! thank you." called patient who stated that she just got the unit and she used it for 24 hour and she was in pain stated that she was in more pain after using it them before using it.Patient was in pain before using the unit.Patient stop using unit called her doctor and waiting for him to call her back.Advised patient to take time test and she stated that she going to wait until she speak with her doctor.Patient will call back with update.
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.
Additional Manufacturer Narrative
Corrections in b4: date of the report additional information in h4: manufacture date, g3, h6 and h10: additional narrative this follow-up report is being submitted to relay additional and corrected information.The orthopak controller 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.Highridge medical will continue to monitor trends.
Event or Problem Description
The sales rep advised that the patient's ankle has been in a lot of pain since wearing the unit.The patient was called and advised that she used the unit for 24 hours and was in more pain after using the unit.The patient was in pain before using the unit.The patient stopped using the unit and called the doctor, she's waiting for a call back.The patient was advised to take a time test.No return noted.Update 12/15/25: the patient was called and her pain level was a 10.

• 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: 23982516
• Report Number: 0002242816-2026-00160
• Device Sequence Number: 10703901
• Product Code: LOF
• UDI-Device Identifier: 00812301020232
• UDI-Public: 00812301020232
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 04/10/2026

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 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: 01/06/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• 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: 34 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic