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 Codes	Discomfort (2330); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: as the onset date for the discomfort and swelling is unknown, the event date is estimated as february of 2026.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 experienced discomfort and swelling.The patient stated that their usual discomfort was rated 6 out of 10, and when putting weight on the foot the discomfort is an 8 out of 10.The patient stated that some days they did not treat with the bone healing system device at all because the sflx 3 coil puts pressure on their swollen tendon.The patient noted that their level of activity had not changed recently but stated that they began putting weight on their foot approximately 3 weeks ago.The patient began taking approximately 10 steps per day, then returning to the wheelchair.The patient¿s doctor requested that the patient be switched to another bone growth stimulator as the patient had not had any bone growth.An orthopak device was shipped to the patient.No further information was provided.
Event or Problem Description
It was reported that the patient experienced discomfort and swelling.The patient stated that their usual discomfort was rated 6 out of 10, and when putting weight on the foot the discomfort is an 8 out of 10.The patient stated that some days they did not treat with the bone healing system device at all because the sflx 3 coil puts pressure on their swollen tendon.The patient noted that their level of activity had not changed recently but stated that they began putting weight on their foot approximately 3 weeks ago.The patient began taking approximately 10 steps per day, then returning to the wheelchair.The patient¿s doctor requested that the patient be switched to another bone growth stimulator as the patient had not had any bone growth.An orthopak device was shipped to the patient.No further information was provided.
Additional Manufacturer Narrative
Additional information in following fields: b4- date of this report, d8-9-device service and availability, g3: date received by manufacturer, h3- device evaluated by manufacturer, h6- evaluation codes.A visual inspection of the customer returned item was performed.Included was a bhs controller part no.1068234 with serial no.(b)(6) received in a shipping box appearing to be in good condition from the visual/cosmetic point of view.The compliance data was downloaded for the bhs controller.The compliance data indicates that the unit treated for 47 hours and was used for 57 days.Review of the dhr indicates that the unit was manufactured on february 9, 2026.No abnormal condition reported on dhr.The unit ran burn-in with sample coil stand alone for ten (10) hours with ac adapter and (10) hours without an ac adapter without a problem.The compliance data was downloaded after the burn in test and a copy is included in the investigation section.The compliance report did accurately record the additional treatment time from the burn in test.Review of the signal was performed and the measurements were within specification.Test/inspections were completed by the quality department on the date of august 7, 2026.Review of complaint history identified (8) total complaints from (apr 22, 2025) to (apr 22, 2026) for pn (1068234, 1068233) 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 that could be considered a causal factor for the reported complaint of "pain".No failure and/or fault condition could be found and confirmed.Therefore, no further actions are required at this time.The device is used for treatment.Ebi will continue to monitor trends.

• 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: 25230633
• Report Number: 0002242816-2026-00064
• Device Sequence Number: 10183958
• Product Code: LOF
• UDI-Device Identifier: 00812301020560
• UDI-Public: 00812301020560
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 05/20/2026

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: 1068234
• Device Catalogue Number: 1068234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female