MAUDE Adverse Event Report: EBI, LLC. BIOMET EBI BONE HEALING SYSTEM SFLX 2 THERAPEUTIC TREATMENT COIL; STIMULATOR, BONE GROWTH, NON-INVASIVE

Model Number	1068226
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a product return, no product evaluation can 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 that the patient experienced pain at the fracture site while using the bhs.It was later reported the pain was below the skin.The patient had not recently increased their level of activity.The patient rated the pain level as 9 out of 10.The patient called their doctor but had to leave a message for a call back.The pain began on (b)(6) 2024, and the patient treated for the last time on (b)(6) 2024.The patient has not experienced any more pain since stopping treatment, and stated the pain stopped within seconds of removing the device.
Additional Manufacturer Narrative
Additional information in g3, h6 and h10: additional narrative.Corrections in d1 and d2: brand name and common device name.This follow-up report is being submitted to relay additional and corrected information.The sflx 2 coil was not returned to (b)(6) for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.Without a product return, no product evaluation can be conducted.The lot number is unknown; therefore, the device history records are unable to be reviewed.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 trend.Reference to related mfr number 0002242816-2025-00002.
Event or Problem Description
It was reported that the patient experienced pain at the fracture site while using the bhs.It was later reported the pain was below the skin.The patient had not recently increased their level of activity.The patient rated the pain level as 9 out of 10.The patient called their doctor but had to leave a message for a call back.The pain began on (b)(6) 2024, and the patient treated for the last time on (b)(6) 2024.The patient has not experienced any more pain since stopping treatment, and stated the pain stopped within seconds of removing the device.No additional patient consequences/ further information has been reported.The bone healing system assembly and sflx- 2 coil were not returned for further evaluation.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM SFLX 2 THERAPEUTIC TREATMENT COIL
• 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: 21136874
• Report Number: 0002242816-2025-00003
• Device Sequence Number: 18061634
• Product Code: LOF
• UDI-Device Identifier: 00812301020515
• UDI-Public: 00812301020515
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/21/2025

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: Health Professional
• Device Model Number: 1068226
• Device Catalogue Number: 1068226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 05/22/2025
• 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: Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic