CRONEX ORTHO L

Additional Manufacturer Narrative

THE RADIOLOGY ADMINISTRATOR HAS NOT RESPONDED TO CO'S WRITTEN REQUEST FOR THE REQUIRED PRODUCT INFO TO PERFORM AN INVESTIGATION. THE RADIOLOGY ADMINISTRATOR COMMUNICATED VERBALLY TO CO'S SALES MANAGEMENT THAT HE REVIEWED CO'S WRITTEN REQUEST WITH THE RADIOLOGIST INVOLVED WITH THE EVENT AND CHAIRMAN OF THE RADIOLOGY DEPT. THEY ELECTED NOT TO REPLY TO CO'S REQUEST AND CONSIDER THE ISSUE CLOSED. CO HAS CONTINUED TO MONITOR COMPLAINT RECORDS WITH NO INDICATION OF A TREND RELATIVE TO THIS ALLEGED EVENT. PLEASE CONSIDER THIS CO'S FINAL REPORT.

Description of Event or Problem

A RADIOLOGIST COMMENTED TO A STERLING DI ACCOUNT EXECUTIVE ALLEGING THAT THE STERLING RADIOGRAPHIC FILM USED IN THE RADIOGRAPHIC STUDY OF A HIP HAD FAILED TO IMAGE A FRACTURE. THE PT REC'D A FOLLOW-UP X-RAY AT ANOTHER LOCATION WHERE UPON THE FRACTURE WAS DETECTED. NO SERIOUS INJURY OR ADVERSE HEALTH CONSEQUENCE WAS INDICATED.