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

Model Number	1068234
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
It was reported by the patient that he treats 7 to 10 hours at night.The patient stated that this caused him pain and he took it off.The patient put the unit on at 9:30pm and removes it at 4am and he has not experienced any pain since then.No further consequences are reported.There was no product returned for further evaluation.
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 october of 2025.
Additional Manufacturer Narrative
Corrections in b4: date of the report, h6: evaluation codes, h3.Additional information in h4: manufacture date, g3, h6: component code and h10: additional narrative.Estimated date of the event b3: unknown.The bhs unit was received for evaluation.A visual inspection of the customer¿s returned product was performed.Included was a bhs controller part no.1068234 with serial no.D89484 received in a shipping box appearing to be in good condition from the visual/cosmetic point of view.The failure was not confirmed for the reported condition of "pain while using the bone stimulator".The controller was tested and operated as intended.Review of complaint history identified (25) total complaints from (oct 2, 2024) to (oct 2, 2025) for pn (1068234) 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.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 actions are required currently.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.Highridge medical will continue to monitor for trend.
Event or Problem Description
It was reported by the patient that he treats 7 to 10 hours at night.The patient stated that this caused him pain and he took it off.The patient put the unit on at 9:30pm and removes it at 4am and he has not experienced any pain since then.No further consequences are reported.There was no product returned for further evaluation.

• Brand Name: BIOMET EBI BONE HEALING 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: 23350898
• Report Number: 0002242816-2025-00127
• Device Sequence Number: 13030739
• Product Code: LOF
• UDI-Device Identifier: 00812301020560
• UDI-Public: 00812301020560
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P790002
• 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): 11/02/2025

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: 1068234
• Device Catalogue Number: 1068234
• 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: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic