MAUDE Adverse Event Report: EBI, LLC. SFLX 1 COIL

Model Number	N/A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced pain while treating with the bone healing system.The patient wore the device overnight for about 8 hours.A few hours into the treatment, she started to feel a very sharp pain inside the ankle.This pain came throughout the night and woke her up several times.She took off the bhs and the pain subsided.The patient advised her foot is broken in 4-year places.The zimvie sales representative advised her to stop using any time she feels pain or discomfort.She plans to try this approach for a few days and will call customer service to update them.She is aware she will be called for more information.It was later reported on (b)(6) 2022, the patient quantifies as 7 out of 10 and under the surface of the skin and in her joint.The patient's doctor has requested that the patient be switched to the orthopak.No additional patient consequences have been reported.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Date of event: the event occurred sometime in july 2022.Medical product: unknown.Therapy date: unknown.Customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported by the sales representative that the patient said she wore the device overnight for about 8 hours.A few hours into the treatment, she started to feel a very sharp pain inside the ankle.This pain came throughout the night and woke her up several times.The customer service spoke with the patient for an update, the first night she used her bhs she had "profound pain" that woke her up.She took off the bhs and pain subsided.The patient advised her foot is broken in 4 different places.Patient quantifies as 7 out of 10 and under the surface of the skin and in her joint.Patient did not speak to her doctor regarding this issue.No additional patient consequences have been reported.The sflx coil was returned for further evaluation.
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, d8-9, g3, h4: device manufacture date, h6: component, investigation type, findings, and conclusions and h10: additional narrative.Investigation summary: the sflx 1 coil was returned for further evaluation.A visual inspection of the customer returned product was performed.Included was one sflx 1 coil part no.1068225 with julian date 21182.The part appeared to be in good condition from the cosmetic/visual point of view.The dhr for the sflx 1 coil was reviewed in the product information section and there were no reports of non-conformances or deviations.The failure was not confirmed for the reported condition of "bhs caused pain".The coil was tested and operates as intended.Review of complaint history identified (0) total complaints from (july 13, 2021) to (july 13, 2022) for pn (1068225) and events related to (pain).Keyword search criteria: (complaint code: medical: pain) the search could not be specified further because the main complaint was pain.Review of the information provided by the customer and the findings from the investigation indicated that no physical and/or device functional condition could be found that could be considered a causal factor for the reported complaint of "pain".No failure and/or fault condition could be found and confirmed.Therefore, no further actions are required at this time.Highridge medical will continue to monitor for trend.Device usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.

• Brand Name: SFLX 1 COIL
• Common Device Name: 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: 15287862
• Report Number: 0002242816-2022-00094
• Device Sequence Number: 14055186
• Product Code: LOF
• UDI-Device Identifier: 00812301020508
• UDI-Public: 00812301020508
• Combination Product (Y/N): N
• 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): 06/27/2024

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
• Device Lot Number: 21182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• 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