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

Model Number	1068239
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported by the sales representative that the patient had terrible pain while using bhs unit.The patient loosened the coil for relief and after 30 minutes the pain was terrible.The patient has a fracture and osteomyelitis.The sales representative told the patient to conduct time-test using the unit.The patient was advised to treat for 30 minutes and gradually increased the time.The patient did not seek any medical treatment.Later, as per the customer service representative, an email was received from sales representative stating that the patient indicated that everything is going great with hourly increase while conducting time-test.No further consequences are reported.The sflx-mini coilette were not returned for further evaluation.
Event or Problem Description
It was reported by the sales representative that the patient had terrible pain while using bhs unit.The patient loosened the coil for relief and after 30 minutes the pain was terrible.The patient has a fracture and osteomyelitis.The sales representative told the patient to conduct time-test using the unit.The patient was advised to treat for 30 minutes and gradually increased the time.The patient did not seek any medical treatment.Later, as per the customer service representative, an email was received from sales representative stating that the patient indicated that everything is going great with hourly increase while conducting time-test.No further consequences are reported.The sflx-mini coilette were not returned for further evaluation.
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, b3: date of event, d2: common device name, catalog number, e: first and last name, g1: contact office, h6: device code.This follow-up report is being submitted to relay additional and corrected information.The device was not returned to highridge medical 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.Highridge medical 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: 21104437
• Report Number: 0002242816-2025-00006
• Device Sequence Number: 9135111
• Product Code: LOF
• UDI-Device Identifier: 00812301020614
• UDI-Public: 00812301020614
• 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): 05/13/2025

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: 1068239
• Device Catalogue Number: 1068239
• 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: 01/08/2025
• Supplement Report FDA Received Date: 05/14/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic