MAUDE Adverse Event Report: EBI, LLC. BIOMET EBI BONE HEALING SYSTEM; SFLX - XL COILETTE

Model Number	1068240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Paresthesia (4421)
Date of Event	12/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the sales representative that the patient told her that she woke up on friday and her toe felt like it was on fire.She stated she had the unit on for 3 or 4 hours.When she took the unit off the burning stopped.Last night she had the unit on for about 8 hours and she felt the burning again.The rep advised the patient to take a break from treating and only wear the unit for 1 hour per day.The customer service representative called the patient for details but had to leave a voicemail for a return call.No product was shipped.Later, the patient called in response to a follow-up letter sent regarding the bone stimulator.Per product surveillance specialist, the patient only experienced the burning sensation when she was sleeping, when asked to rate the pain level she said was near 1000 and as soon as she removed the coil the pain stopped right away.The patient spoke with her doctor who did not prescribe anything and told her to treat during the day for 4 hours per day.Patient described the pain as putting a lit match on her skin.No further consequences are reported.The bhs controller and sflx-xl coilette were not returned for further evaluation.
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.
Additional Manufacturer Narrative
Additional information in following fields- b4: date of this report, g3: date received by manufacturer, h6: evaluation codes corrected data in following fields - d4: catalog number, g4: pma/510(k) #.This follow-up report is being submitted to relay additional and corrected information.The device was not returned to highridge medical for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record was unable to be reviewed as the lot number of the product is unknown.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.Highridge medical will continue to monitor for trends.Related mfr# 0002242816-2025-00032.
Event or Problem Description
It was reported by the sales representative that the patient told her that she woke up on friday and her toe felt like it was on fire.She stated she had the unit on for 3 or 4 hours.When she took the unit off the burning stopped.Last night she had the unit on for about 8 hours and she felt the burning again.The rep advised the patient to take a break from treating and only wear the unit for 1 hour per day.The customer service representative called the patient for details but had to leave a voicemail for a return call.No product was shipped.Later, the patient called in response to a follow-up letter sent regarding the bone stimulator.Per product surveillance specialist, the patient only experienced the burning sensation when she was sleeping, when asked to rate the pain level she said was near 1000 and as soon as she removed the coil the pain stopped right away.The patient spoke with her doctor who did not prescribe anything and told her to treat during the day for 4 hours per day.Patient described the pain as putting a lit match on her skin.No further consequences are reported.The bhs controller and sflx-xl coilette were not returned for further evaluation.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM
• Common Device Name: SFLX - XL COILETTE
• 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: 21470933
• Report Number: 0002242816-2025-00033
• Device Sequence Number: 19724701
• Product Code: LOF
• UDI-Device Identifier: 00812301020621
• UDI-Public: 00812301020621
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P790002/S026
• 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): 05/07/2025

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: 02/26/2025
• Supplement Report FDA Received Date: 05/08/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic