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

Model Number	1068240
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Neuropathy (1983); Numbness (2415)
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 had discomfort and numbness while treating.The customer service representative called the patient for details and found that after using the bhs for 30 minutes she had a foot cramp.Then, she put the coil on for 1 1/2 hours and the foot was cold and tingly.The patient used it again in the morning with the same result.The patient spoke with her doctor¿s office, and they advised her to stop wearing the unit and if the foot continues to feel cold and tingly to go to the er and make sure the blood vessels are working.The patient stated the cold foot, and tingling has not stopped since last night.The patient is going to the er if the foot does not stop feeling cold and will call back with an update.No further consequences are reported.The bhs controller and sflx-xl coilette were not returned for further evaluation.
Event or Problem Description
It was reported by the sales representative that the patient had discomfort and numbness while treating.The customer service representative called the patient for details and found that after using the bhs for 30 minutes she had a foot cramp.Then, she put the coil on for 1 1/2 hours and the foot was cold and tingly.The patient used it again in the morning with the same result.The patient spoke with her doctor¿s office, and they advised her to stop wearing the unit and if the foot continues to feel cold and tingly to go to the er and make sure the blood vessels are working.The patient stated the cold foot, and tingling has not stopped since last night.The patient is going to the er if the foot does not stop feeling cold and will call back with an update.No further consequences are reported.The bhs controller and sflx-xl coilette were not returned for further evaluation.
Additional Manufacturer Narrative
Related manufacturer's report: mfr#0002242816-2025-00008.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.

• 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: 21138771
• Report Number: 0002242816-2025-00007
• Device Sequence Number: 6982678
• Product Code: LOF
• UDI-Device Identifier: 00812301020621
• UDI-Public: 00812301020621
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/20/2025

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): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 05/21/2025
• 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): Yes
• 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: 46 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic