MAUDE Adverse Event Report: EBI, LLC. BIOMET EBI BONE HEALING SYSTEM; STIMULATOR, BONE GROWTH, NON-INVASIVE

Model Number	1068240
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient wore the bhs device for 3 minutes and had redness, swelling, and pain at the sight.The patient stated that she used the device successfully once.The next time she treated, the patient had pain on the outer side of her foot which is not where she is currently treating but is the location of a previous surgery and there is hardware implanted there.The patient stated described the pain as a burning sensation.She rated the pain level an 8 or a 9 out of 10, with 10 being the highest.When she turned the device off her skin was red and inflamed.The redness was gone the next day, but the foot was still inflamed.She tried again this morning and had the same pain and discomfort beneath the surface of the skin occurred within 3 minutes.The patient has not spoken to her doctor but has a follow up visit soon.The patient wears the coil on her foot and the controller rests at her waist.A new bhs controller, 28" cable, sflx coilette and a standard coilette was shipped to the patient.It was later reported that the patient stated that she has not spoken to her doctor about the pain.The patient said she has been treating with the new bhs unit and coil and is having no issues, the pain has subsided.
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, h2, h8 and h3.Additional information in d4, d8-9, g3, h4: device manufacture date, h6: component, investigation type, findings, and conclusions and h10: additional narrative.Investigation summary: 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 failure was not confirmed for the reported condition of "pain/discomfort".The coil was tested and operates as intended.Review of complaint history identified (b)(4) total complaints from ((b)(6) 2023) to ((b)(6) 2024) for pn (1068240) and events related to (burn).Keyword search criteria: (complaint code: medical: burn) 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 that could be considered a causal factor for the reported complaint of "burn".No failure and/or fault condition could be found and confirmed.Therefore, no further actions are required at this time.Device usage: this device is 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.
Event or Problem Description
It was reported that the patient wore the bhs device for 3 minutes and had redness, swelling, and pain at the sight.The patient stated that she used the device successfully once.The next time she treated, the patient had pain on the outer side of her foot which is not where she is currently treating but is the location of a previous surgery and there is hardware implanted there.The patient stated described the pain as a burning sensation.She rated the pain level an 8 or a 9 out of 10, with 10 being the highest.When she turned the device off her skin was red and inflamed.The redness was gone the next day, but the foot was still inflamed.She tried again this morning and had the same pain and discomfort beneath the surface of the skin occurred within 3 minutes.The patient has not spoken to her doctor but has a follow up visit soon.The patient wears the coil on her foot and the controller rests at her waist.A new bhs controller, 28" cable, sflx coilette and a standard coilette was shipped to the patient.It was later reported that the patient stated that she has not spoken to her doctor about the pain.The patient said she has been treating with the new bhs unit and coil and is having no issues, the pain has subsided.No additional patient consequences have been reported.The sflx-xl coilette was returned for further evaluation.
Event or Problem Description
It was reported that the patient wore the bhs device for 3 minutes and had redness, swelling, and pain at the sight.The patient stated that she used the device successfully once.The next time she treated, the patient had pain on the outer side of her foot which is not where she is currently treating but is the location of a previous surgery and there is hardware implanted there.The patient stated described the pain as a burning sensation.She rated the pain level an 8 or a 9 out of 10, with 10 being the highest.When she turned the device off her skin was red and inflamed.The redness was gone the next day, but the foot was still inflamed.She tried again this morning and had the same pain and discomfort beneath the surface of the skin occurred within 3 minutes.The patient has not spoken to her doctor but has a follow up visit soon.The patient wears the coil on her foot and the controller rests at her waist.A new bhs controller, 28" cable, sflx coilette and a standard coilette was shipped to the patient.It was later reported that the patient stated that she has not spoken to her doctor about the pain.The patient said she has been treating with the new bhs unit and coil and is having no issues, the pain has subsided.No additional patient consequences have been reported.The sflx-xl coilette was returned for further evaluation.
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, d4: expiration date, g4: pma/510(k)#, h4: device manufacture date, h5: labeled for single use, h6: evaluation codes.Additional information: b4: date of this report, g3: date received by manufacturer.The sflx xl coilette was received for evaluation.The dhr was reviewed in the investigation section.All evaluation results are included in the product evaluation section.The failure was not confirmed for the reported condition of "pain/discomfort".The coil was tested and operates as intended.(b)(4) for pn (1068240) and events related to (burn).Keyword search criteria: (complaint code: medical: burn) 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 that could be considered a causal factor for the reported complaint of "burn".No failure and/or fault condition could be found and confirmed.Therefore, no further actions are required at this time.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM
• 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: 18956148
• Report Number: 0002242816-2024-00038
• Device Sequence Number: 4540745
• Product Code: LOF
• UDI-Device Identifier: 00812301020621
• UDI-Public: 00812301020621
• 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): 02/23/2026

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
• Device Lot Number: 23300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 08/22/2024; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2023
• 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: 46 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic