SKELETAL DYNAMICS INC.

Description of Event or Problem

AN IMPLANTED ALIGN RADIAL STEM LOOSENED AFTER FIVE MONTHS, REQUIRING REVISION SURGERY.

Additional Manufacturer Narrative

THE INSTRUCTIONS FOR USE FOR THE ALIGN RADIAL HEAD SYSTEM STATES THE FOLLOWING: "THE ALIGN RADIAL HEAD SYSTEM SHOULD NOT BE USED IF ANY OF THE FOLLOWING ARE PRESENT: ACTIVE OR LATENT INFECTION, INSUFFICIENT QUANTITY OR QUALITY OF BONE AND/OR SOFT TISSUE, MATERIAL SENSITIVITY, OR PATIENTS WHO ARE UNWILLING OR INCAPABLE OF FOLLOWING POST-SURGICAL CARE INSTRUCTIONS." NEITHER THE IMPLANT NOR IMAGES FROM THE CASE WERE MADE AVAILABLE FOR ANALYSIS; HOWEVER, THE PATIENT WAS DESCRIBED BY THE REP ATTENDING THE CASE AS HAVING 'BAD BONE', WITH LUCENCY AROUND THE RADIAL NECK. THIS LIKELY SUGGESTS THAT THE PATIENT WAS CONTRAINDICATED FOR USE OF THE ALIGN RADIAL HEAD SYSTEM.