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	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 sales representative that the patient called complaining about wearing the unit.The sales representative indicated that the doctor wants to switch to orthopak assembly.Customer service representative requested a prescription for orthopak from doctor.Later, customer service representative called the patient to obtain additional information.Per patient, the bhs unit caused pain in his ankle where he wore the coil.The pain level was around 8-9, 10 being the worst.The patient indicated that he could not sleep while treating bhs unit.The patient indicated that the bone was not healing because he could not keep the unit on.A new orthopak assembly was sent to the patient.No further consequences were reported.Bhs assembly and sflx 2 therapeutic treatment coil were not returned.
Additional Manufacturer Narrative
Estimated date of event b3: july 2025.Without a product return, no product evaluation is able to be conducted.The device history records were reviewed; however, no discrepancies were found.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 called complaining about wearing the unit.The sales representative indicated that the doctor wants to switch to orthopak assembly.Customer service representative requested a prescription for orthopak from doctor.Later, customer service representative called the patient to obtain additional information.Per patient, the bhs unit caused pain in his ankle where he wore the coil.The pain level was around 8-9, 10 being the worst.The patient indicated that he could not sleep while treating bhs unit.The patient indicated that the bone was not healing because he could not keep the unit on.A new orthopak assembly was sent to the patient.No further consequences were reported.Bhs assembly and sflx 2 therapeutic treatment coil were received for evaluation.
Additional Manufacturer Narrative
Additional information h6: evaluation codes, investigation summary: a visual inspection of the customer returned product was performed.Included was one sflx 2 coil part no.1068226 with a julian date 25125.The part appeared to be in good condition from the cosmetic/visual point of view.The dhr for the sflx 2 coil was reviewed in the product information section and there were no reports of non-conformances or deviations.The sflx 2 coil was tested, and it operates as intended.The failure was not confirmed for the reported condition of "bhs unit caused pain".Review of complaint history identified (2) total complaints from ((b)(6), 2024) to ((b)(6), 2025) for pn (b)(6) and events related to (pain).Keyword search criteria: (complaint code: medical: pain) the search could not be specified further because the main complaint was pain.Review of the information provided by the customer and the findings from the investigation indicated that no physical and/or device functional condition could be found and that could be considered a causal factor for the reported complaint of "pain".No failure and/or fault conditions could be found and confirmed.Therefore, no further actions are required currently.Device usage: this device was used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.

• 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: 22644446
• Report Number: 0002242816-2025-00091
• Device Sequence Number: 18295154
• Product Code: LOF
• UDI-Device Identifier: 00812301020515
• UDI-Public: 00812301020515
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/13/2025

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: 1068226
• Device Lot Number: 25125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/29/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2025
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic