COCHLEAR¿ VISTAFIX® VXI300 IMPLANT 4MM

Additional Manufacturer Narrative

THE REPORTED ADVERSE EVENT IS ASSOCIATED WITH A RETURNED DEVICE; HOWEVER, THE PROVIDED CLINICAL INFORMATION WAS REVIEWED BY THE MANUFACTURER AND NO SPECIFIC DEVICE ANALYSIS IS DEEMED NECESSARY AT THIS TIME. PREVIOUS PRODUCT EXAMINATIONS HAVE NOT SHOWED ANY RELATIONSHIP BETWEEN A PRODUCT GEOMETRICAL DEVIATION AND THE REPORTED CLINICAL COMPLICATION. ADDITIONALLY, THERE ARE NO INDICATIONS THAT A PRODUCT FAILURE HAS CONTRIBUTED TO THE REPORTED ISSUE. ADVERSE SKIN REACTIONS AROUND THE BAHA ABUTMENT, RANGING FROM SLIGHT REDNESS TO INFECTED TISSUE, ARE COMMON COMPLICATIONS WITH BAHA IMPLANTS, AND CAN OCCUR AT ANY TIME FOLLOWING IMPLANTATION. THE REPORT FREQUENCY FOR THESE COMPLICATIONS IS BEING MONITORED UNDER CBAS COMPLAINT AND MEDICAL DEVICE REPORTING DATA MONITORING PLAN AND THE STATUS IS UPDATED ON A MONTHLY BASIS. THIS EVENT IS ADDED TO THIS MONITORING.

Description of Event or Problem

PER THE CLINIC, THE PATIENT EXPERIENCED A CONTINUOUS SKIN OVERGROWTH. SUBSEQUENTLY, THE ABUTMENT AND INTERNAL FIXTURE WAS EXPLANTED ON (B)(6) 2025. REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT.