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The OGmend® implant system is for the use with screws as part of a fracture fixation plate system in long bones in rescue scenarios where the screw has lost purchase due to screw loosening, back out, or breakage and the stability of the plate construct is at risk. The OGmend® Implant System is for use in skeletally mature patients.

The OGmend® Implant System is a sterile, single-use device intended to provide supplemental fixation to restore stability if the screw/bone interface of a plate and screw system becomes mechanically compromised. When inserted into a prepared bone pilot hole, the OGmend® Implant System is designed to use the principles of interference fit to serve as a rescue technology to secure a bone screw and stabilize the fracture construct. The OGmend® Implant System is manufactured from woven polyethylene terephthalate (PET), with an inner diameter of 6.5mm and an outer diameter of 7.5mm, and can be used with screws ranging in diameter from 3.5mm to 6.5mm. The OGmend® Implant System is 100mm in length and is cut intraoperatively to the appropriate length. When a screw loses stability due to loosening, backout, or breakage, the OGmend® Implant System is intended to restore stability. The device is placed into a prepared hole after removal of the failed screw, and a new screw is inserted though the inner diameter of the OGmend® Implant System, in order to generate mechanical interferences and improve the stability of the screw and bone-plate construct.