MAGEC GENERATION 2B MODIFIED SPINAL BRACING AND DISTRACTION SYSTEM

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

INFORMATION WAS RECEIVED THAT ONE OF THE IMPLANTED RODS FAILED TO LENGTHEN SO BOTH RODS WERE REMOVED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS LOST DURING TRANSIT. THE CUSTOMER REPORTED THAT ONE OF THE IMPLANTED RODS FAILED TO LENGTHEN, RESULTING IN THE REMOVAL OF BOTH RODS. ALTHOUGH PHYSICAL EVALUATION WAS NOT POSSIBLE, RADIOGRAPHIC IMAGES PROVIDED BY THE CUSTOMER WERE REVIEWED. BASED ON THE IMAGES, ONE ROD APPEARS TO HAVE DISTRACTED APPROXIMATELY 9.5¿12 MM, WHILE THE OTHER SHOWS NO EVIDENCE OF DISTRACTION. BOTH RODS EXHIBIT INTACT AND PROPERLY ASSEMBLED END CAPS. DUE TO THE LIMITED CLARITY OF THE IMAGES, IT WAS NOT POSSIBLE TO ASSESS FOR POTENTIAL INTERNAL COMPONENT ASSEMBLY ISSUES. CONSEQUENTLY, THE ROOT CAUSE OF THE REPORTED FAILURE COULD NOT BE DEFINITIVELY DETERMINED. A REVIEW OF THE DHR DOCUMENTS INDICATES THE DEVICE WAS MANUFACTURED BY THE SPECIFIED REQUIREMENT AT THE TIME AND MET ALL THE REQUIRED INSPECTIONS UPON RELEASE TO FINISHED GOODS.

Description of Event or Problem

NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.