GALAFLEX 3DR

Description of Event or Problem

AS REPORTED, ON (B)(6) 2026, TWO PIECES OF GALAFLEX 3DR SCAFFOLD WERE USED BY THE SURGEON. UPON CLOSURE, IT WAS OBSERVED THAT THE RIM HAD DETACHED FROM A PORTION OF THE MESH ON ONE SIDE. IT WAS FURTHER REPORTED THAT WHEN THE MESH WAS GENTLY FOLDED, THE RIM NEARLY DETACHED. A SECOND PIECE OF MESH WAS OPENED, AND THE RIM WAS NOTED TO HAVE DETACHED AT SEVERAL LOCATIONS; DESPITE THIS, THE SURGEON OPTED TO PROCEED WITH IMPLANTATION. ADDITIONALLY, IT WAS OBSERVED THAT THE MESH WAS LESS STRETCHY AND FELT DIFFERENT. THERE WAS NO PATIENT HARM OR INJURY.

Additional Manufacturer Narrative

AS REPORTED, THE GALAFLEX 3DR SCAFFOLD RIM WAS NOTED TO HAVE DETACHED AT SEVERAL LOCATIONS; DESPITE THIS, THE SURGEON OPTED TO PROCEED WITH IMPLANTATION. ADDITIONALLY, IT WAS OBSERVED THAT THE MESH WAS LESS STRETCHY AND FELT DIFFERENT. BASED ON THE INFORMATION PROVIDED AND WITHOUT HAVING THE SAMPLE TO EVALUATE, NO CONCLUSION CAN BE MADE. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO THE SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF 163 UNITS. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.