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

Model Number	1068226
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient that he was having pain and burning sensation while using the unit.The pain started about a month after receiving the unit.The patient's rated the pain as an 8 on a scale of 1 to 10, with 10 being the highest.The patient did not increase his daily activity.The patient spoke with his doctor and was told to call sales representative the patient took tylenol, but it did not help.The patient was advised to conduct a time test after he was pain free.The patient was advised to call back with any issues during the time test.No further consequences have been reported at this time.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore 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
Corrections in b4: date of the report, b5: event description, d3: manufacturer, g1: contact office, g6: type of report.Additional information in h4: device manufacture date, h6: component, investigation type, findings, and conclusions and h10: additional narrative.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 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.Highridge medical will continue to monitor for trend.
Event or Problem Description
It was reported by the patient that he was having pain and burning sensation while using the unit.The pain started about a month after receiving the unit.The patient's rated the pain as an 8 on a scale of 1 to 10, with 10 being the highest.The patient did not increase his daily activity.The patient spoke with his doctor and was told to call sales representative the patient took tylenol, but it did not help.The patient was advised to conduct a time test after he was pain free.The patient was advised to call back with any issues during the time test.No further consequences have been reported at this time.The bone healing system (bhs) has not been returned for further evaluations.
Additional Manufacturer Narrative
Udi related data quality updates only - a supplemental report is being submitted to address the discrepancies between fda medwatch form 3500a and gudid.Corrections: d1: brand name, d2a: device common name, d4: model number, g4: pma/510(k)#, h5: labeled for single use, h6: evaluation codes.Additional information: b4: date of this report, g3: date received by manufacturer.Device lot number is unknown as the product was not returned.
Event or Problem Description
It was reported by the patient that he was having pain and burning sensation while using the unit.The pain started about a month after receiving the unit.The patient's rated the pain as an 8 on a scale of 1 to 10, with 10 being the highest.The patient did not increase his daily activity.The patient spoke with his doctor and was told to call sales representative the patient took tylenol, but it did not help.The patient was advised to conduct a time test after he was pain free.The patient was advised to call back with any issues during the time test.No further consequences have been reported at this time.The bone healing system (bhs) has not been returned for further evaluations.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM SFLX 2 THERAPEUTIC TREATMENT COILETTE
• 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: 18151761
• Report Number: 0002242816-2023-00127
• Device Sequence Number: 6622119
• 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,Followup
• Report Date (Section B): 09/07/2025

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: 1068226
• Device Catalogue Number: 1068226
• 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; Not provided
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 06/13/2024; 09/08/2025
• 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.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic