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

Model Number	1068226
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: as the onset date of the patient's symptoms is unknown, the event date is estimated as 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.The device is used for treatment.
Event or Problem Description
It was reported that the patient had pain in their foot and stated that their foot felt like it was burning.It was later reported that the sflx 2 coil gives the patient a burning sensation on their foot.Some nights the burning sensation is rated at a 10 out of 10.After treating at night, the patient rated the burning sensation a 3 out of 10.The patient shared they are still wearing the boot while treating even though the doctor told them they do not need to.The patient did not discuss the burning sensation with their doctor and did not use any creams.The skin is red and painful with no blisters and no bumps.The patient normally uses the device starting around 10pm and wakes up feeling the burn by 3-5 am every night.The patient noted that there were no issues with the original sflx 2 coil received in the assembly, the burning sensation began with the replacement sflx 2 coil.A new slfx 2 coil was shipped to the patient.
Additional Manufacturer Narrative
Corrections: d1: brand name, d2a: device common name, d4: model number, g4: pma/510(k)#, h4: device manufacture date, h5: labeled for single use, h6: evaluation codes.Additional information: b4: date of this report, g3: date received by manufacturer.A visual inspection of the customer returned product was performed.Included was one sflx 2 coil part no.1068226 with julian date 25188.The part appeared to be in good condition from the cosmetic/visual point of view.The dhr for the sflx 2 coil was reviewed in the product information section and there were no reports of non-conformances or deviations.The sflx 2 coil was tested and it operates as intended.Refer to the attached technical data sheet in the investigation section.The failure was not confirmed for the reported condition of "burning and redness sflx 2 coil".The coil was tested and operates as intended.Review of complaint history identified (5) total complaints from ((b)(6) 2024) to ((b)(6) 2025) for pn (1068226) 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.
Event or Problem Description
It was reported that the patient had pain in their foot and stated that their foot felt like it was burning.It was later reported that the sflx 2 coil gives the patient a burning sensation on their foot.Some nights the burning sensation is rated at a 10 out of 10.After treating at night, the patient rated the burning sensation a 3 out of 10.The patient shared they are still wearing the boot while treating even though the doctor told them they do not need to.The patient did not discuss the burning sensation with their doctor and did not use any creams.The skin is red and painful with no blisters and no bumps.The patient normally uses the device starting around 10pm and wakes up feeling the burn by 3-5 am every night.The patient noted that there were no issues with the original sflx 2 coil received in the assembly, the burning sensation began with the replacement sflx 2 coil.A new slfx 2 coil was shipped to the patient.

• 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: 23990049
• Report Number: 0002242816-2026-00162
• Device Sequence Number: 18688295
• Product Code: LOF
• UDI-Device Identifier: 00812301020515
• UDI-Public: 00812301020515
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/19/2026

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: 1068226
• Device Catalogue Number: 1068226
• Device Lot Number: 25188
• 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: 01/07/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2025
• 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: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic