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 Code	Pain (1994)
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 experienced pain while using the bhs assembly.The patient indicated that the pain level was at a 8 or 10 on a scale of 1 to10, 10 being the worst.The patient contacted their doctor, and the physician advised the patient to stop using the unit.No further consequences are reported.The bhs unit and sflx-xl coilette were not returned for further evaluation.
Additional Manufacturer Narrative
Corrections in b4: date of the report, d1: brand name and d2a: device common name, h6: evaluation codes, h3.Additional information in d8-9: device return date, h4: manufacture date, g3, and h10: additional narrative.Estimated date of the event b3: unknown.A visual inspection of the customer returned product was performed.Included was one sflx xl coilette part no.1068240 with (b)(6).The part appeared to be in good condition from the cosmetic/visual point of view.The dhr for the sflx xl coilette was reviewed in the product information section and there were no reports of non-conformances or deviations.The sflx xl coilette was tested, and it operates as intended.The failure was not confirmed for the reported condition of "patient experienced pain while using the bone stimulator".The coil was tested and operated as intended.Review of complaint history identified (14) total complaints from ((b)(6) 2024) to ((b)(6) 2025) for pn (1068240) 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.(b)(6) medical will continue to monitor for trend.Related mfr number 0002242816-2025-00042-01.
Event or Problem Description
It was reported by the sales representative that the patient experienced pain while using the bhs assembly.The patient indicated that the pain level was at a 8 or 10 on a scale of 1 to 10, 10 being the worst.The patient contacted their doctor, and the physician advised the patient to stop using the unit.No further consequences are reported.The bhs unit and sflx-xl coilette were 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: 21667793
• Report Number: 0002242816-2025-00043
• Device Sequence Number: 8175337
• Product Code: LOF
• UDI-Device Identifier: 00812301020621
• UDI-Public: 00812301020621
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/24/2025

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 Lot Number: 24305
• 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: 03/21/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2024
• 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: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic