MAUDE Adverse Event Report: EBI, LLC. BIOMET EBI BONE HEALING SYSTEM; 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
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.
Event or Problem Description
It was reported that the patient said with the device that the pain is worse.The patient stated that she had a doctor visit where he changed her splint, and she was at a pain level of 12 out of 10.The first day she used our bhs the patient experienced discomfort in all of her toes on that foot at all of the operative sites.Her pain level was at a 7 or 8 out of 10 while treating with the device.The patient claims no new activities as she is non-weight-bearing.On saturday and sunday, her treatment time was for approximately 7 hours and on both days the pain level was at a 7 or 8 out of 10.On monday, the patient's treatment time was 10 hours, and her pain level was a 10 out of 10.The patient advised she has regularly been on pain medication since her surgery.The patient also stated that at times the pain medications do not help her pain.The patient advised she has some relief when she turns off the device, but she "grins and bears¿ the pain while treating.The patient claims she has swelling with or without the device.The patient also stated that she has an intermittent low-grade fever since before she started using our device.The patient called and spoke with the physician¿s assistance at her doctor's office.The physician¿s assistance suggested she call her sales rep for advice on her discomfort.The physician¿s assistance advice on the fever was that it is a normal response to the surgery.The patient will perform the time test to see if she can better tolerate treatment and report back to the sales representative or customer service with any issues or questions.
Event or Problem Description
It was reported that the patient said with the device that the pain is worse.The patient stated that she had a doctor visit where he changed her splint, and she was at a pain level of 12 out of 10.The first day she used our bhs the patient experienced discomfort in all of her toes on that foot at all of the operative sites.Her pain level was at a 7 or 8 out of 10 while treating with the device.The patient claims no new activities as she is non-weight-bearing.On saturday and sunday, her treatment time was for approximately 7 hours and on both days the pain level was at a 7 or 8 out of 10.On monday, the patient's treatment time was 10 hours, and her pain level was a 10 out of 10.The patient advised she has regularly been on pain medication since her surgery.The patient also stated that at times the pain medications do not help her pain.The patient advised she has some relief when she turns off the device, but she "grins and bears¿ the pain while treating.The patient claims she has swelling with or without the device.The patient also stated that she has an intermittent low-grade fever since before she started using our device.The patient called and spoke with the physician¿s assistance at her doctor's office.The physician¿s assistance suggested she call her sales rep for advice on her discomfort.The physician¿s assistance advice on the fever was that it is a normal response to the surgery.The patient will perform the time test to see if she can better tolerate treatment and report back to the sales representative or customer service with any issues or questions.Later, an attempt was made by phone to follow up on the patient's doctor appointment.The patient stated that she was experiencing more pain every time she used the device.The doctor confirmed that she could stop treatment due to the pain.The doctor did not prescribe anything for the pain.No additional patient consequences have been reported.The sflx-2 coil was returned for further evaluation.
Additional Manufacturer Narrative
The sflx-2 coil was received for evaluation.A visual inspection of the customer returned product was performed.Included was one sflx 2 coil part no.1068226 with (b)(6) (b)(4).The part appeared to be in good condition from the cosmetic/visual point of view.The dhr was reviewed.All evaluation results did not show any discrepancies.The failure was not confirmed for the reported condition of "issue with controller".The coil was tested and operates as intended.Review of complaint history identified (6) total complaints from ((b)(6) 2023) to ((b)(6) 2024) for pn (1068226) 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 that could be considered a causal factor for the reported complaint of "pain".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 said with the device that the pain is worse.The patient stated that she had a doctor visit where he changed her splint, and she was at a pain level of 12 out of 10.The first day she used our bhs the patient experienced discomfort in all of her toes on that foot at all of the operative sites.Her pain level was at a 7 or 8 out of 10 while treating with the device.The patient claims no new activities as she is non-weight-bearing.On saturday and sunday, her treatment time was for approximately 7 hours and on both days the pain level was at a 7 or 8 out of 10.On (b)(6), the patient's treatment time was 10 hours, and her pain level was a 10 out of 10.The patient advised she has regularly been on pain medication since her surgery.The patient also stated that at times the pain medications do not help her pain.The patient advised she has some relief when she turns off the device, but she "grins and bears¿ the pain while treating.The patient claims she has swelling with or without the device.The patient also stated that she has an intermittent low-grade fever since before she started using our device.The patient called and spoke with the physician¿s assistance at her doctor's office.The physician¿s assistance suggested she call her sales rep for advice on her discomfort.The physician¿s assistance advice on the fever was that it is a normal response to the surgery.The patient will perform the time test to see if she can better tolerate treatment and report back to the sales representative or customer service with any issues or questions.Later, an attempt was made by phone to follow up on the patient's doctor appointment.The patient stated that she was experiencing more pain every time she used the device.The doctor confirmed that she could stop treatment due to the pain.The doctor did not prescribe anything for the pain.No additional patient consequences have been reported.The sflx-2 coil 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 2 coil 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 "issue with controller".The coil was tested and operates as intended.Review of complaint history identified (b)(4) total complaints from (mar 18, 2023) to (mar 18, 2024) for pn ((b)(4)) 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 that could be considered a causal factor for the reported complaint of "pain".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: 19102405
• Report Number: 0002242816-2024-00051
• Device Sequence Number: 7428017
• Product Code: LOF
• UDI-Device Identifier: 00812301020515
• UDI-Public: 00812301020515
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 1068226
• Device Catalogue Number: 1068226
• Device Lot Number: 24037
• 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: 04/12/2024
• Supplement Report FDA Received Date: 08/15/2024; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• 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.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic