MAUDE Adverse Event Report: EBI, LLC. SFLX 1 COIL; STIMULATOR, BONE GROWTH, NON-INVASIVE (COIL)

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Medical product: unknown.Therapy date: unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is complete a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the device that is placed on her foot is causing pain in her legs.The patient is using the coil on her left foot.The pain began the second day after starting her treatment with the stimulator.There was pain after the second night of wearing the unit for 10 hours.The pain level was at a 10.The patient could not stand from the pain on the shin (front of the leg) on both legs.The pain is still there on both legs.The patient rates the pain level at a 7 or 8 on a scale of 1 to 10, with 10 being the highest.The patient has not increased her daily activity.The patient contacted the doctor¿s office had advised her to contact the sales representative.The patient is taking noraco 5/325mg every 6 hours as needed for pain.The patient had this medication at home.The patient wore the unit for a couple of hours today.She had the same pain before she started wearing the bhs but not as painful.The patient spoke to the doctor about the pain.The doctor stated that she was compensating when walking with the right leg.Zimmer biomet advised the patient to speak with the doctor prior to using the stimulator as the pain was on both legs and she is treating the left foot.It was reported that no further information is available.
Additional Manufacturer Narrative
Corrections in b4: date of the report, b5: event description, d3: manufacturer g1: contact office, g6: type of report, h2, h8 and h3.Additional information in d4, g3, h4: device manufacture date, h6: component, investigation type, findings, and conclusions and h10: additional narrative.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.Without a product return, no product evaluation can be conducted.The lot number is unknown; therefore, the device history records are unable to be reviewed.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.(b)(6) medical will continue to monitor for trend.
Event or Problem Description
It was reported by the sales rep that the device that she is wearing on her foot is causing pain in her legs.I explained that the device should not have any effect on her legs but she says she is scared to continue wearing the device.Spoke to the patient's husband who stated that the pain started the second day after starting her treatment with the stimulator.The pain after the second night of wearing the unit for 10 hours.The pain level was a 10.The patient is using the coil on her left foot.The patient could not stand from the pain on the shin (front of the leg) on both legs.The pain is still there on both legs.The pain level is right now at a 7 or 8.The patient has not increased her daily activity.The patient called the doctor's office spoke to a secretary who told the patient to contact the sales rep.The patient stated that she contacted the sales rep before she called the doctor.The patient is taking norco 5/325mg every 6 hours as needed for pain.The patient had this medication at home.The patient wore the unit for a couple of hours today.She had the same pain before she started wearing the bhs but not as painful.The patient spoke to the doctor about it and was told that it was that she was compensating when walking with the right leg.I told the patient to speak with the doctor prior to using the stimulator as she had the pain on both legs and she is treating the left foot.No additional patient consequences have been reported.The sflx-1 coil was not returned for further evaluation.

• Brand Name: SFLX 1 COIL
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE (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: drashti patel ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 12256619
• Report Number: 0002242816-2021-00132
• Device Sequence Number: 20115722
• Product Code: LOF
• UDI-Device Identifier: 00812301020508
• UDI-Public: 00812301020508
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 1068225
• 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: 07/09/2021
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic