TRANSLOC 3D

Additional Manufacturer Narrative

FIVE ATTEMPT WERE MADE TO GATHER DATA FROM THE OPERATIVE PHYSICIAN, AND 5 ATTEMPTS WERE MADE TO SPEAK TO FACILITY PERSONELL. THE PHYSICIAN'S OPERATIVE NOTES WERE FINALLY RELEASED TO MANUFACTURER THROUGH THE PHYSICIAN'S ATTORNEY. THE PHYSICIAN'S OPERATIVE NOTE REFLECTED THE PRESENCE OF POOR BONE QUALITY AS A LIKELY REASON FOR THE MALPOSTION OF THE IMPLANT. THE PHYSICIAN'S OFFICE INDICATED THAT AT THE PATIENT'S 2 WEEK FOLLOW-UP, THE PATIENT HAD NO COMPLAINTS OF PAIN OR COMPLAINTS RELATING TO THE MALPOSITIONED DEVICE. NO OTHER INFO AVAILABLE.

Description of Event or Problem

SI JOINT FUSION IMPLANT (SCREW) WAS MALPOSITIONED UPON IMPLANTATION. ATTEMPTS TO BACK UP THE IMPLANT TO A MORE IDEAL DEPTH INCREASED THE MALPOSTION. THE BONE WAS NOTED BY THE OPERATIVE PHYSICIAN TO BE "QUITE SOFT." ATTEMPTS TO RETRIEVE THE IMPLANT WITH A CLAMP RESULTED IN THE IMPLANT ADVANCING INTO THE PRESACRAL SPACE. PATIENT PROCEDURE WAS CONCLUDED, AND THE OPERATIVE INCISION WAS CLOSED. THE PATIENT WAS TRANSPORTED TO THE ER FOR EVALUATION BY A VASCULAR SURGEON WHERE A CTA SCAN WAS PERFORMED. PATIENT REMAINED STABLE THROUGHOUT. PATIENT WAS RELEASED FROM THE ER WITHOUT INTERVENTION OR REMOVAL OF THE IMPLANT.