UNKNOWN FUTURA¿ CONICAL SUBTALAR IMPLANT
Received Nov 26, 2023 · Event occurred Oct 30, 2023
Report 0001649390-2023-00325 · MDR key 18207742
Device
Generic name
Prosthesis, Toe, Hemi-, Phalangeal
Manufacturer
Tornier IncCatalog number
UNK_WTB
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Implant Pain
- Implant Pain
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A RETROSPECTIVE DATA COLLECTION OF THE RADIOGRAPHIC CLINICAL OBSERVATIONAL STUDY ON PATIENTS TREATED FOR FLAT FOOT WITH THE FUTURA¿ CONICAL SUBTALAR IMPLANT SYSTEM (CSI) WAS CONDUCTED TO COLLECT SAFETY AND EFFICACY/PERFORMANCE OF THE FUTURA¿ CONICAL SUBTALAR IMPLANT SYSTEM (CSI). IT WAS FOUND THAT A PATIENT HAD PAIN AT THE SINUS TARSI (SOLVED WITH SCREW REMOVAL).
Additional Manufacturer Narrative
THE ALLEGED EVENT COULD NOT BE CONFIRMED, SINCE NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR OR THE ARTICLE. MORE DETAILED INFORMATION ABOUT THE PATIENT MEDICAL HISTORY, THE EVENT CIRCUMSTANCES, AND MEDICAL REPORTS MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY. H3 OTHER TEXT : DEVICE NOT AVAILABLE.