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
Section b3: as the day of the event is unknown, the event date is estimated as february of 2025.Without a product return, no product evaluation is able to be conducted.The device history records have been requested but not yet provided, therefore the manufacturing date is unknown.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
It was reported by the sales representative that the patient was experiencing pain.It was later reported by the patient that her pain increases when she is treating with the unit.This has been occurring since the patient started treatment.The patient has not increased her level of daily activity.The patient is only treating during the day for around 8 hours per day.It was later reported that the pain level is a 5 on a scale of 1-10, with 10 being the worst.The patient started treating for up to 4 hours per day and will continue to increase her treatment time.On (b)(6) 2025, reported that the patient is treating for about 4 to 5 hours or until she experiences pain.The pain was rated a 9 on a scale of 1-10.The patient contacted their doctor due to the pain and was prescribed percocet.The patient is going to continue treatment as much as she can tolerate.No further information was provided.The product has not been returned for evaluation.
Event or Problem Description
It was reported by the sales representative that the patient was experiencing pain.It was later reported by the patient that her pain increases when she is treating with the unit.This has been occurring since the patient started treatment.The patient has not increased her level of daily activity.The patient is only treating during the day for around 8 hours per day.It was later reported that the pain level is a 5 on a scale of 1-10, with 10 being the worst.The patient started treating for up to 4 hours per day and will continue to increase her treatment time.On (b)(6) 2025, reported that the patient is treating for about 4 to 5 hours or until she experiences pain.The pain was rated a 9 on a scale of 1-10.The patient contacted their doctor due to the pain and was prescribed percocet.The patient is going to continue treatment as much as she can tolerate.No further information was provided.The product has not been returned for evaluation.
Additional Manufacturer Narrative
Additional information in following fields- b4: date of this report, g3: date received by manufacturer, h2, h4: device manufacture date, h6: evaluation codes 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 information.The device was not returned to (b)(6) medical 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.

• 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: 21920873
• Report Number: 0002242816-2025-00059
• Device Sequence Number: 8907655
• Product Code: LOF
• UDI-Device Identifier: 00812301020560
• UDI-Public: 00812301020560
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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: 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: 04/28/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2024
• 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: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic