IDYS-ALIF
Received Nov 14, 2024 · Event occurred Jul 10, 2019
Report 3009962553-2024-00001 · MDR key 20687973
Device
Generic name
Idys-alif Cage 26x32 - H14mm - 14
Manufacturer
Clariance SasCatalog number
24520414-S
Lot number
H463X-H725Y
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
NA · Female
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
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.
Description of Event or Problem
PATIENT REPORTS AN ALLERGIC REACTION TO THE METAL IN AN IMPLANT USED IN SURGERY.
Description of Event or Problem
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.