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

Model Number	1068229
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
The patient reported she was in a lot of pain while treating.The patient stated that she wore the unit for 5 hours.Then took a break for a few hours.Then wore it again for 90 minutes and began feeling pain.The patient did not tell the doctor, only the sales rep.The patient will conduct the time test and call back with any issues.No further consequences are reported.There was no product return for further evaluation.
Additional Manufacturer Narrative
Section b3: the date of the event is unknown and is estimated to have occurred in december of 2025.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.
Additional Manufacturer Narrative
Additional information: b4- date of this report, g3- date received by manufacturer, h2 ¿ follow up type.Corrected data: d2 ¿ common device name, g4-pma/510(k)#.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
The patient reported she was in a lot of pain while treating.The patient stated that she wore the unit for 5 hours.Then took a break for a few hours.Then wore it again for 90 minutes and began feeling pain.The patient did not tell the doctor, only the sales rep.The patient will conduct the time test and call back with any issues.No further consequences are reported.There was no product return for further evaluation.
Event or Problem Description
The patient reported she was in a lot of pain while treating.The patient stated that she wore the unit for 5 hours.Then took a break for a few hours.Then wore it again for 90 minutes and began feeling pain.The patient did not tell the doctor, only the sales rep.The patient will conduct the time test and call back with any issues.No further consequences are reported.
Additional Manufacturer Narrative
Additional information in following fields- b4: date of this report, g3: date received by manufacturer, h6: evaluation codes.Corrected data in following fields ¿ b2: outcomes attributed to adverse event, g2: report source.D4: the lot number of the product is unknown.Attempts were made to obtain additional information, however, none was provided.H4: as the lot number of the product is unknown, the date of manufacture could not be determined.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 unable to be reviewed as the lot number of the product is unknown.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: 23961422
• Report Number: 0002242816-2026-00157
• Device Sequence Number: 21235347
• 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): 05/21/2026

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: 1068229
• Device Catalogue Number: 1068229
• 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): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/25/2026; 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Unknown