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

Model Number	N/A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Discomfort (2330); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 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 that the patient experienced an allergic reaction while she was treating with the bone healing system.The patient stated that she has a copper allergy.The patient¿s bhs controller and coil make her foot swell up and cause discomfort.It was later reported on (b)(6) 2022, that the patient confirmed the coil used was a slfx coilette.The patient further advised she had a full body allergic reaction to the bhs.The skin on her whole body was itchy.The patient did not experience redness, blisters, welts, no other skin issues, or pain.The patient was advised by her physician to discontinue treatment with the bone healing system, and she would be switched to an ortho pak assembly.No additional patient consequences have been reported.
Additional 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 allergic reaction, swelling, and discomfort.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.
Event or Problem Description
It was reported that the patient experienced an allergic reaction while she was treating with the bone healing system.The patient stated that she has a copper allergy.The patient¿s bhs controller and coil make her foot swell up and cause discomfort.It was later reported on aug 5, 2022, that the patient confirmed the coil used was a slfx coilette.The patient further advised she had a full-body allergic reaction to the bhs.The skin on her whole body was itchy.The patient did not experience redness, blisters, welts, no other skin issues, or pain.The patient was advised by her physician to discontinue treatment with the bone healing system, and she would be switched to an ortho pak assembly.No additional patient consequences have been reported.

• Brand Name: SFLX - COILETTE
• Common Device Name: 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: 15289273
• Report Number: 0002242816-2022-00097
• Device Sequence Number: 12547492
• Product Code: LOF
• UDI-Device Identifier: 00812301020607
• UDI-Public: 00812301020607
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P790002/S026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1068238
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female