IDYS-ALIF
Report
- Report Number
- 3009962553-2024-00001
- Event Type
- Injury
- Date Received
- November 14, 2024
- Date of Event
- July 10, 2019
- Report Date
- November 14, 2024
- Manufacturer
- CLARIANCE SAS
- Product Code
- OVD
- UDI-DI
- 03700780626922
- PMA / PMN Number
- K172083
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
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.
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.
PATIENT REPORTS AN ALLERGIC REACTION TO THE METAL IN AN IMPLANT USED IN SURGERY.
PATIENT REPORTS AN ALLERGIC REACTION TO THE METAL IN AN IMPLANT USED IN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1195764 | IDYS-ALIF | IDYS-ALIF CAGE 26X32 - H14MM - 14 | OVD | CLARIANCE SAS | H463X-H725Y | 03700780626922 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |