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

Model Number	1068238
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the sales representative that the patient experienced discomfort while using the bhs assembly.The patient indicated that the area of treatment is sore and has pain after she uses the stim.The patient wore the unit for 6 to 10 hours when she had discomfort.The patient contacted their doctor, and the physician advised only to treat for 1 hour a day.The patient was going to conduct the time-test and call back if they face any issue.No further consequences are reported.The bhs unit, sflx coilette and sflx-xl coilette were not returned for further evaluation.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The device history records are unable to be reviewed.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 in the following fields - b4: date of this report, g3: date received by manufacturer.H2: follow up type, h6: evaluation codes.Corrected data in the following fields - d2: common device name, d3: catalog number, h6: device code.Section b3: as the day of the event is unknown, the event date is estimated as february of 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 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.Related manufacturers reports: mfr#0002242816-2025-00041 and mfr#0002242816-2025-00039.
Event or Problem Description
It was reported by the sales representative that the patient experienced discomfort while using the bhs assembly.The patient indicated that the area of treatment is sore and has pain after she uses the stim.The patient wore the unit for 6 to 10 hours when she had discomfort.The patient contacted their doctor, and the physician advised only to treat for 1 hour a day.The patient was going to conduct the time-test and call back if they face any issue.No further consequences are reported.The bhs unit, sflx coilette and sflx-xl coilette were not returned for further evaluation.

• 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: 21619594
• Report Number: 0002242816-2025-00040
• Device Sequence Number: 20542444
• Product Code: LOF
• UDI-Device Identifier: 00812301020607
• UDI-Public: 00812301020607
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/10/2025

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: 1068238
• Device Catalogue Number: 1068238
• 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: 03/17/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic