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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/10/2025
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 has pain while using the unit and the sales representative advised the patient to conduct time test.Later, the customer service representative called that patient to gather more information, however had to leave a voicemail.On march 17 2025, a call was received from patient who stated that she had pain after 3 hours of treatment.It started the first day she started treating on the right foot.The pain is on the top of the foot where the bone is fractured.The pain level is like an 8 and the patient has discontinued the treatment.After the patient stops treating, she falls back asleep and does not know how long it takes the pain to go away.The patient has not increased her daily activities but is walking with the injured foot.The patient does not take anything for pain and only contacted the sales representative, did not call the doctor.The patient is doing time test and is up to 4 hours a day.The patient will call us with any updates.No further consequences were reported.The bhs unit and sflx-xl coilette were not returned for investigation.
Additional Manufacturer Narrative
Corrections in b4: date of the report, d2a: common name.Additional information in g3, h6 and h10: additional narrative.Lot number of the product is unknown (unk) as the product was returned.This follow-up report is being submitted to relay additional and corrected information.The sflx xl coilette 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.(b)(6) medical will continue to monitor trends.Related mfr number is 0002242816-2025-00051-01.
Event or Problem Description
It was reported by the sales representative that the patient has pain while using the unit and the sales representative advised the patient to conduct time test.Later, the customer service representative called that patient to gather more information, however had to leave a voicemail.On (b)(6) 2025, a call was received from patient who stated that she had pain after 3 hours of treatment.It started the first day she started treating on the right foot.The pain is on the top of the foot where the bone is fractured.The pain level is like an 8 and the patient has discontinued the treatment.After the patient stops treating, she falls back asleep and does not know how long it takes the pain to go away.The patient has not increased her daily activities but is walking with the injured foot.The patient does not take anything for pain and only contacted the sales representative, did not call the doctor.The patient is doing time test and is up to 4 hours a day.The patient will call us with any updates.No further consequences were reported.The bhs unit and sflx-xl coilette were not returned for investigation.

• 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: 21708893
• Report Number: 0002242816-2025-00052
• Device Sequence Number: 20032993
• 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): 09/03/2025

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
• Device Catalogue 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: 03/27/2025
• Supplement Report FDA Received Date: 09/04/2025
• 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: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic