L5000 TOE FILLER CUSTOM INSOLE

Description of Event or Problem

IT WAS REPORTED THAT ALLEGEDLY INSERT DOES NOT PROVIDE FULL CONTACT WITH PATIENTS TOE THAT CAUSED A ULCER, THE PATIENT DID SEEK MEDICAL ATTENTION

Additional Manufacturer Narrative

IT WAS REPORTED THAT ALLEGEDLY INSERT DOES NOT PROVIDE FULL CONTACT WITH PATIENTS TOE THAT CAUSED A ULCER. MEDICAL INTERVENTION WAS REQUIRED, IT WAS REPORTED BY THE DOCTOR THE MEDICAL TREATMENT THAT WAS PROVIDED WAS DEBRIDEMENT OF ULCERATIONS, OFFLOADING, AND APPLICATIONS OF SKIN GRAFT SUBSTITUTE. THE TOE FILLER AND SHOES WERE RETURNED TO ENOVIS FOR EVALUATION. THE INVESTIGATION FOUND THAT THERE WAS NO DEFECT FOUND WITH THE SHOES AND THE INVESTIGARTION WITH TOE FILLERS FOUND THAT THE TOE FILLER WAS MIS ASSEMBLED 3/8 OF SPACE FROM FILLER TO AMP SITE WAS NOT INCLUDED.