|
Device | INFUSE BONE GRAFT/LT-CAGE TAPERED FUSION DEVICE |
Generic Name | Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction |
Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P000058 |
Supplement Number | S020 |
Date Received | 10/27/2006 |
Decision Date | 12/21/2007 |
Product Code |
NEK |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR CHANGES TO THE PACKAGE INSERT AND KIT BOX TEXT BASED ON REPORTS ASSOCIATED WITH SEVERAL TYPES OF AES. THESE AES WERE THE PRESENCE OF FLUID-FILLED CYSTS OR RADIOGRAPHIC EVIDENCE OF PERI-IMPLANT TRANSIENT BONE RESORPTION. IT?S BELIEVED THAT OVERPACKING OF THE ACS COMPONENT WITHIN A CONFINED SPACE AND/OR HYPERCONCENTRATING THE RHBMP-2 SOLUTION WERE RESPONSIBLE FOR THE AES. |