Implant Failure: STRATOS System for Pectus Repair

Combined tensile, compressive, bending, and torsional loading on the implant during each breathing cycle caused loosening and fatigue fractures, which led to failure. Excessive rubbing at the fracture and loosening site caused the release of large amounts of titanium in the surrounding tissue, which may lead to metallosis. Long and sharp pieces of failed implant in the cardiothoracic region is a grave danger to vital organs. All patients should be closely followed, and in our opinion, all implants should be removed. Serious reconsideration for clinical use of this implant is necessary.