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
Additional Manufacturer Narrative
Section b3: as the day of the event is unknown, the event date is estimated as october of 2025.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 pain during treatment with the orthopak.The patient was switched to the bone healing system (bhs).It was later reported that the patient tried using the orthopak for about a week.No further information could be provided regarding how long the patient was able to treat with the device before the pain started.
Event or Problem Description
It was reported that the patient was experiencing pain during treatment with the orthopak.The patient was switched to the bone healing system (bhs).It was later reported that the patient attempted to use the orthopak for about a week.No further information could be provided regarding how long the patient was able to treat with the device before the pain started.No further consequences are reported.The orthopak was received for further evaluation.
Additional Manufacturer Narrative
Corrected data in the following fields - g1: contact office name, and email address.Additional information in the following fields- b4: date of this report, b5: additional narrative, d8, d9, g3: date received by manufacturer, h2, h3, h6: evaluation codes.The orthopak assembly was received for evaluation, but due to the nature of the complaint and the information provided within the complaint file, only the orthopak stimulator was evaluated.A visual inspection of the customer¿s returned product was performed.Included was one orthopak stimulator, part no.1067718, with serial number (b)(6), received in a shipping box.The part received appears to be in good condition from a visual/cosmetic standpoint.The compliance data for the orthopak stimulator was downloaded on march 17, 2026.The compliance data indicates the unit was treated for 0 days, 1 hour, and 16 minutes.The dhr review indicates that the unit was manufactured on july 19, 2025.There were no non-conformances or deviations reported on the dhr.The op unit ran a burn-in stand-alone ¿battery¿ for more than 24 hours without issue.Review of the information provided by the customer and the findings from the investigation indicated that no physical and/or device functional condition could be found, and that could be considered a causal factor for the reported complaint of "pain".No failure and/or fault conditions could be found and confirmed.Therefore, no further action is required at this time.Review of complaint history identified (02) total complaints from (b)(6) 2024) to (b)(6), 2025) for pn (b)(4) and events related to (pain).Keyword search criteria: (complaint code: medical: pain) the search could not be specified further because the main complaint was pain.Device usage: this device was used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.

• 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: 23568616
• Report Number: 0002242816-2025-00141
• Device Sequence Number: 9924681
• Product Code: LOF
• UDI-Device Identifier: 00812301020232
• UDI-Public: 00812301020232
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/16/2026

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: 1067718
• Device Catalogue Number: 1067718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/17/2025
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2025
• 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: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic