MAUDE Adverse Event Report: EBI, LLC. BONE HEALING SYSTEM SFLX - COILETTE; NON-INVASIVE, BONE GROWTH, STIMULATOR (COIL)

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2020.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002242816-2020-00051.
Event or Problem Description
It was reported that the patient was experiencing pain and a burning sensation from using the bone healing system (bhs) with the sflx coilette.The patient was treating her left foot with the device during the night.The patient said that when she first started treatment, she would wake up in pain after 7 or 8 hours.The patient reported that the pain was an 8, on a scale of 1 to 10.The patient described the pain as deep and below the surface of the skin.The patient said that the pain subsides after 30 to 60 minutes and then she can fall back asleep.A few days later, after 3 to 5 hours of treating, the patient woke from a searing burning sensation.The patient said that her skin was not red and the coilette was not hot.The patient tried treating without a sock underneath the coil and the patient still experienced the burning sensation.The patient had an appointment with her doctor and was provided with a replacement bhs controller and coilette for treatment.It was reported that no further information is available.

• Brand Name: BONE HEALING SYSTEM SFLX - COILETTE
• Common Device Name: NON-INVASIVE, BONE GROWTH, STIMULATOR (COIL)
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 10086645
• Report Number: 0002242816-2020-00052
• Device Sequence Number: 3081514
• Product Code: LOF
• UDI-Device Identifier: 00812301020607
• UDI-Public: 00812301020607
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P790002/S026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2020

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: N/A
• Device Catalogue Number: 1068238
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 61