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

Model Number	1068240
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Diarrhea (1811); Nausea (1970)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B4: estimated date of event is march 2025.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 doctor indicated that the patient had nausea, diarrhea and pain from (b)(6) unit.Later, the customer service representative called the patient to obtain additional information.The patient stated that she had nausea, diarrhea and pain while using the stim.The patient indicated that they are taking pain medication percocet and nausea medication.The patient treated for 4 to 5 hours or until felt pain, the patient is going to continue the treatment unless otherwise specified.The patient will call back with any updates.Later, the complaint specialist called the patient to verify if there was any other medical intervention and verify onset of nausea/ diarrhea symptoms but had to leave a voicemail message requesting for a call back.A call back was received from the patient indicating that nausea and diarrhea started last month- (b)(6) 2025.The patient contacted her primary care doctor and was prescribed nausea medication.The patient stated that she takes the medication as needed and continues the use of bone stim.No further consequences are reported.The sflx-xl coilette was not returned for further evaluation.
Additional Manufacturer Narrative
B3: estimated date of event is march 2025.Corrections in b4: date of the report, additional information in h4: manufacture date, g3, h6 and h10: additional narrative.This follow-up report is being submitted to relay additional information.The bhs assembly 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 trends.Related mfr number 0002242816-2025-00056.
Event or Problem Description
It was reported by the sales representative that the doctor indicated that the patient had nausea, diarrhea and pain from bhs unit.Later, the customer service representative called the patient to obtain additional information.The patient stated that she had nausea, diarrhea and pain while using the stim.The patient indicated that they are taking pain medication percocet and nausea medication.The patient treated for 4 to 5 hours or until felt pain, the patient is going to continue the treatment unless otherwise specified.The patient will call back with any updates.Later, the complaint specialist called the patient to verify if there was any other medical intervention and verify onset of nausea/ diarrhea symptoms but had to leave a voicemail message requesting for a call back.A call back was received from the patient indicating that nausea and diarrhea started last month- (b)(6) 2025.The patient contacted her primary care doctor and was prescribed nausea medication.The patient stated that she takes the medication as needed and continues the use of bone stim.No further consequences are reported.The sflx-xl coilette was not returned for further evaluation.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM SFLX- XL 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: 21876452
• Report Number: 0002242816-2025-00057
• Device Sequence Number: 7653743
• Product Code: LOF
• UDI-Device Identifier: 00812301020621
• UDI-Public: 00812301020621
• 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): 06/23/2025

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: 1068240
• 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: 04/21/2025
• Supplement Report FDA Received Date: 06/24/2025
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic