MAUDE Adverse Event Report: EBI, LLC. SFLX - XL COILETTE

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

Zimvie complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.Medical product: ebi bone healing system sflx xl coilette.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 Description

It was reported that the patient gets a burning sensation in his foot "like it is on fire" approximately once per week.The patient stated that the bhs gives him a hot feeling in his foot and toes.The patient claims there are no issues with his skin such as redness, swelling, blisters, or welts.The sensation is under the skin and feels like the hardware in his foot from surgery is heating up and burning him.The patient rates this pain as shocking and an 8 to 10 out of 10.He has paused treatment for 4 to 5 minutes then continues to treat without another incident.The patient is sleeping while he treats and when this occurs.His foot and coil are under the covers.The patient has an allergy to iodine but no other allergies.The patient did not consult with a medical professional.He only called the zimvie sales representative.The patient will continue to treat with bhs and will break up treatments into smaller time frames if he feels it is necessary.No additional patient consequences have been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device not was returned to zimvie for investigation.The reported event was not verifiable after the investigation associated with burning sensation and pain.The device history record was reviewed and no discrepancies related to the reported event were found.No physical and/or functional condition could be found after the dhr that could be considered a causal factor for the reported complaint.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly zimvie will continue to monitor for trends.The following sections have been updated: b4: date of this report added.D3: manufacturer updated.G1: contact office updated.G3: date received by manufacturer added.G6: type of report updated.H2: follow up type added.H3: device evaluated by manufacturer updated to no.H6: component code - 761 - coil.H6: impact code 4649 - unanticipated adverse device effect.H6: clinical code 2146 - burning sensation.H6: clinical code 1994 - pain.H6: device code updated to 2682 - patient-device incompatibility.H6: investigation code added to 3331 - analysis of production records.H6: investigation code added to 4114 - device not returned.H6: investigation code added to 4119 ¿ insufficient information available.H6: investigation findings code added to 3221: no findings available.H6: investigation conclusion added 4315 - cause not established.H10: additional narratives/data.The following sections have been corrected: h6: device code updated to 2993: adverse event without identified device or use problem.

Event Description

It was reported that the patient gets a burning sensation in his foot "like it is on fire" approximately once per week.The patient stated that the bhs gives him a hot feeling in his foot and toes.The patient claims there are no issues with his skin such as redness, swelling, blisters, or welts.The sensation is under the skin and feels like the hardware in his foot from surgery is heating up and burning him.The patient rates this pain as shocking and an 8 to 10 out of 10.He has paused treatment for 4 to 5 minutes then continues to treat without another incident.The patient is sleeping while he treats and when this occurs.His foot and coil are under the covers.The patient has an allergy to iodine but no other allergies.The patient did not consult with a medical professional.He only called the zimvie sales representative.The patient will continue to treat with bhs and will break up treatments into smaller time frames if he feels it is necessary.No additional patient consequences have been reported.

• Brand Name: SFLX - XL COILETTE
• Type of Device: COIL
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 15255299
• MDR Text Key: 298202482
• Report Number: 0002242816-2022-00092
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020621
• UDI-Public: 00812301020621
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790002/S026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1068240
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male