MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

Description of Event or Problem

INFORMATION WAS RECEIVED THAT THE DURING A LENGTHENING SESSION, X-RAY IMAGES REVEALED A LOCKING PIN FAILURE. AS THE PATIENT IS AT THE END OF THEIR LENGTHENING, THE ROOD WILL NOT BE REPLACED AND PATIENT WILL CONTINUE TO DEFINITIVE FUSION.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

THE DEVICE WAS NOT RECEIVED AS THERE WAS NO ASSIGNED RMA, HOWEVER, THE REPORTED EVENT WAS ABLE TO BE VISUALLY CONFIRMED. INVESTIGATION OF THE PATIENT X-RAYS IT APPEARS ONE ROD¿S LEAD SCREW HAS SEPARATED FROM THE MAGNET MODULE, INDICATIVE OF A PIN FAILURE. BOTH RODS¿ ENDCAPS ARE INTACT. THE COMPLAINT COMMENT REGARDING THE BROKEN ROD STILL DISTRACTING DURING THE LAST LENGTHENING IS A RESULT OF THE PIN FAILURE AND LEAD SCREW UN-COUPLING FROM THE MAGNET MODULE. THE BROKEN IMPLANT¿S DISTRACTION ROD CAN NOW SLIDE FREELY IN AND OUT OF THE HOUSING TUBE IF UNCONSTRAINED BY THE CONSTRUCT LENGTH ITSELF. THE INTACT ROD WAS LENGTHENED AND THAT DISTRACTIVE FORCE AND LENGTH GAIN EXERTED ON THE CONSTRUCT CAUSED THE BROKEN IMPLANT¿S DISTRACTION ROD TO SLIDE SLIGHTLY TO ACCOMMODATE THAT DISTRACTIVE FORCE AND CONSTRUCT LENGTH GAIN. 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.