MAUDE Adverse Event Report: CLARIANCE SAS IDYS-ALIF; IDYS-ALIF CAGE 26X32 - H14MM - 14

Catalog Number	24520414-S
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A patient reported an allergic reaction following the implantation of idys-alif device during a surgical procedure performed in 2019.The patient experienced symptoms consistent with an allergic response.This constitutes an adverse health effect that results from the use of an idys-alif device.This event is reportable as an injury.
Event or Problem Description
Patient reports an allergic reaction to the metal in an implant used in surgery.
Event or Problem Description
Patient reports an allergic reaction to the metal in an implant used in surgery.
Additional Manufacturer Narrative
A patient reported an allergic reaction following the implantation of idys-alif device during a surgical procedure performed in 2019.The patient experienced symptoms consistent with an allergic response.This constitutes an adverse health effect that results from the use of an idys-alif device.This event is reportable as an injury.01/09/2025: analysis conclusion - based on available records, the idys-alif cage used were conforming to clariance's specification (control report and raw material certificates).The potential for an allergic reaction is a contra-indication that is addressed in the ifu.

• Brand Name: IDYS-ALIF
• Common Device Name: IDYS-ALIF CAGE 26X32 - H14MM - 14
• Manufacturer (Section D): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• Manufacturer (Section G): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• Manufacturer Contact: quang tran ; 18 rue robespierre; beaurains, 62217 ; FR 62217
• MDR Report Key: 20687973
• Report Number: 3009962553-2024-00001
• Device Sequence Number: 15313607
• Product Code: OVD
• UDI-Device Identifier: 03700780626922
• UDI-Public: (01)03700780626922(17)220802(10)H463X-H725Y
• Combination Product (Y/N): N
• PMA/510(K) Number: K172083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 11/14/2024

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: Health Professional
• Device Expiration Date: 08/02/2022
• Device Catalogue Number: 24520414-S
• Device Lot Number: H463X-H725Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female