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	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
The patient reported experiencing irritation with the coil, the patient stated it is on the lateral side of her knee.Patient said the coil is not tight, it is a raised area.She wore the unit for 2 months stated it started about a week - 2 weeks ago.Patient is active but not with the unit.The patient uses a walker and she treats at night.The patient was advised to stop wearing the unit and call the doctor.Patient will call back with an update.Cs spoke with the patient and she stated it is not from the coil rubbing on her skin.Sales rep stated that the doctor was the one to call them and requested a switch to an opak.No further information was provided.
Event or Problem Description
The patient reported experiencing irritation with the coil, the patient stated it is on the lateral side of her knee.Patient said the coil is not tight, it is a raised area.She wore the unit for 2 months stated it started about a week - 2 weeks ago.Patient is active but not with the unit.The patient uses a walker and she treats at night.The patient was advised to stop wearing the unit and call the doctor.Patient will call back with an update.Cs spoke with the patient and she stated it is not from the coil rubbing on her skin.Sales rep stated that the doctor was the one to call them and requested a switch to an opak.No further information was provided.
Additional Manufacturer Narrative
Additional information: b4: date of this report, g3: date received by manufacturer, h2, h10, h11 corrected data: d3: email address, g1: email address.Section b3: as the onset date of the pain is unknown, the event date is estimated as 2025.This follow-up report is being submitted to relay additional and corrected information.The device 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.The device is used for treatment.Ebi will continue to monitor for 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: 23572451
• Report Number: 0002242816-2025-00146
• Device Sequence Number: 10172779
• Product Code: LOF
• UDI-Device Identifier: 00812301020560
• UDI-Public: 00812301020560
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/12/2026

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
• 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: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2025
• 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; Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic