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
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 december 2025.
Event or Problem Description
It was reported by the patient that she experienced pain after five hours of treatment.The patient will complete the time test, starting at 4 hours per day for 2 days.Increasing by an hour every two days.No further consequences were reported.The bhs controller was not returned.
Event or Problem Description
It was reported by the patient that she experienced pain after five hours of treatment.The patient will complete the time test, starting at 4 hours per day for 2 days.Increasing by an hour every two days.No further consequences were reported.The bhs controller was not returned.
Additional Manufacturer Narrative
Additional information: b4- date of this report, g3- date received by manufacturer, h2 ¿ follow up type.Corrected data: g4-pma/510(k)#, h6: method evaluation code.This follow-up report is being submitted to relay additional and corrected information.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 trends.
Event or Problem Description
It was reported by the patient that she experienced pain after five hours of treatment.The patient will complete the time test, starting at 4 hours per day for 2 days.Increasing by an hour every two days.It was later reported that the patient stopped experiencing pain after reducing treatment time.The patient treats during the day and removes the device at night.No further information was provided.
Additional Manufacturer Narrative
Additional information- b4: date of this report, b5: additional narrative, g3: date received by manufacturer, h3, h6: evaluation codes this follow-up report is being submitted to relay additional 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 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: 24086158
• Report Number: 0002242816-2026-00001
• Device Sequence Number: 9683995
• Product Code: LOF
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2026

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: Other
• Device Model Number: 1068234
• Device Catalogue Number: 1068234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/25/2026; 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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.
• Patient Age: 67 YR
• Patient Sex: Unknown