MAUDE Adverse Event Report: EBI, LLC. BIOMET EBI BONE HEALING SYSTEM; SFLX 2 COIL

Model Number	1068226
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Headache (1880); Sleep Dysfunction (2517)
Date of Event	08/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.This event was previously reported under mfr#0002242816-2024-00118.This report is being submitted to reflect the potential involvement of the sflx 2 coil in the event.
Event or Problem Description
It was reported that whenever the patient wears the stimulator no one is able to wake her up.The patient also mentioned that since wearing the stimulator, everyone in the house has had headaches, including herself.The patient stated her brother and sister-in-law get a headache while she is using the unit.The family members were in the same room while she was treating.No medical devices implanted.The patient does not have a pacemaker or defibrillator.The patient mentioned that she had not used the device in three days.The patient was instructed to contact her doctor and not to use the unit until it was approved by her doctor.No further information was provided.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM
• Common Device Name: SFLX 2 COIL
• 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: 21287676
• Report Number: 0002242816-2025-00022
• Device Sequence Number: 13144002
• Product Code: LOF
• UDI-Device Identifier: 00812301020515
• UDI-Public: 00812301020515
• 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
• Report Date (Section B): 01/30/2025

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 Catalogue Number: 1068226
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic