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

Model Number	N/A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: (b)(6) 2020.Concomitant medical product: unknown.Concomitant medical product: 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
First attempt made by email.As per customer experience rep, (b)(6), it was reported by the sales rep that the patient mentioned swelling of the ankle on both the outer and inner areas.Patient stated that the swelling on the right foot started last week.The patient used the unit for 61 days straight then the swelling started.The patient stated that the she woke with soreness.The pain level was at a seven.The pain is below the skin.Sharp shooting pains.The pain has not gone away.The pain level is the same.The patient has not increased her daily activity.The patient spoke to the doctor.The patient has an appointment on (b)(6) 2020.The patient stated that she is not going to use the stimulator until she speaks to her doctor.
Event or Problem Description
It was reported that the patient mentioned swelling of the ankle on both the outer and inner areas.Patient stated that the swelling on the right foot started last week.The patient used the unit for 61 days straight then the swelling started.The patient stated that the she woke with soreness.The pain level was at a seven.The pain is below the skin.Sharp shooting pains.The pain has not gone away.The pain level is the same.The patient has not increased her daily activity.The patient spoke to the doctor.The patient has an appointment.The patient stated that she is not going to use the stimulator until she speaks to her doctor the patient called and stated that the swelling and the pain was from the metal in her foot which was removed.Not from the unit.The doctor had her use the unit again which has actually promoted 20% bone growth.She is keeping and using the unit with no issues.The spinal pak device was not returned for evaluation.No further consequences have been reported.
Additional Manufacturer Narrative
Corrections: b4 date of this report, b5 updated the product was not returned for evaluation, d3 manufacturer address and email address, d4 unique identifier (udi) number, g1 contact office, and manufacturer site, g6 type of report.Additional information: g3 date received by manufacturer, h4 device manufacture date, h6 component, investigation type, findings, and conclusions, h10 and h11.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/certificate of conformance was reviewed, and no discrepancies related to the reported event were found.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: SFLX 1 COIL
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE
• 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: 11112581
• Report Number: 0002242816-2021-00002
• Device Sequence Number: 11664824
• Product Code: LOF
• UDI-Device Identifier: 00812301020508
• UDI-Public: 00812301020508
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/12/2024

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: 12/11/2020
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 06/14/2024
• 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