MAUDE Adverse Event Report: EBI, LLC. SFLX - MINI 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 Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's doctor's note mentioned pain.The patient has been experiencing pain with the device and the sflx mini coilette but thought the pain was from the surgery.The patient stated that the pain was from the middle of the nine-month treatment until the end.The patient has a non-union fracture and is going to have surgery again in march.The patient stated that her previous surgery was "done wrong" and that a bone will be taken out of her hip.The patient will conduct the time test if she has pain with the new unit.She told the doctor about the pain which is why she is having revision surgery.No additional information has been provided by the patient.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2023.Concomitant medical products: 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 patient's doctor's note mentioned pain.The patient has been experiencing pain with the device and the sflx mini coilette but thought the pain was from the surgery.The patient stated that the pain was from the middle of the nine-month treatment until the end.The patient has a non-union fracture and is going to have surgery again in march.The patient stated that her previous surgery was "done wrong" and that a bone will be taken out of her hip.The patient will conduct the time test if she has pain with the new unit.She told the doctor about the pain which is why she is having revision surgery.No additional information has been provided by the patient.No product was returned for evaluation.
Additional Manufacturer Narrative
Corrections - b4: date of this report added, b5: updated the product was not returned for evaluation, d3: manufacturer address and email address, d4: udi, d9: device not available for evaluation, g1: contact office and manufacturer site, g6: report type, h6: device code additional information - g3, h6: impact code, component code, method, results.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 was unable to be reviewed as the lot number is unknown.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 - MINI COILETTE
• 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: brianne mcgill ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 16558293
• Report Number: 0002242816-2023-00034
• Device Sequence Number: 6138905
• Product Code: LOF
• UDI-Device Identifier: 00812301020614
• UDI-Public: 00812301020614
• 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): 06/17/2024

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: 1068239
• Device Lot Number: N/A
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 06/18/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic