GALAFLEX 3DR

Additional Manufacturer Narrative

AS REPORTED, THE GALAFLEX 3DR SCAFFOLD RIM ALMOST CAME OFF WHILE FOLDING. ADDITIONALLY, IT WAS OBSERVED THAT THE MESH WAS LESS STRETCHY AND FELT DIFFERENT. BASED ON THE INVESTIGATION FINDINGS OF DEVICE 1 FROM THE SAME LOT, THE MOST PROBABLE CAUSE MAY BE RELATED TO THE MANUFACTURING PROCESS. ANALYSIS OF THE RETURNED SAMPLE (DEVICE 1) IDENTIFIED THE MESH RIM HAS BECOME DETACHED/TORE FROM THE MESH AND WAS FOUND TO BE MANUFACTURING RELATED AS IT DOES NOT APPEAR THE MESH WAS PROPERLY MELTED AND FUSED WITH THE RIM. HOWEVER, WITHOUT THE SAMPLE TO EVALUATE A DEFINITIVE CAUSE AS TO WHY THE RIM MAY HAVE DETACHED FROM THIS MESH (DEVICE 2) COULD NOT BE DETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO THE SPECIFICATION. THIS EMDR REPRESENTS THE GALAFLEX 3DR (DEVICE 2). ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE OTHER GALAFLEX 3DR (DEVICE 1). 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.

Description of Event or Problem

AS REPORTED ON (B)(6) 2026, ONE PIECE OF GALAFLEX 3DR SCAFFOLD WAS USED BY THE SURGEON. WHILE FOLDING, IT WAS OBSERVED THAT THE RIM ALMOST CAME OFF. DUE TO THIS, ANOTHER PIECE WAS OPENED BY THE SURGEON, AND THE RIM CAME OFF IN FEW SPOTS, AND THE SURGEON OPTED TO PROCEED WITH THE IMPLANTATION WITH IT. ADDITIONALLY, IT WAS OBSERVED THAT THE MESH WAS LESS STRETCHY AND FELT DIFFERENT. THERE WAS NO PATIENT HARM OR INJURY.