INSPAN

Description of Event or Problem

ANATOMY WAS CHALLENGING TO COMPRESS AND LOCK TO THE 18MM INSPAN IMPLANT (THICK SPINOUS PROCESS AND HARD BONE). IT WAS NOTICED POST-SURGERY THAT THE IMPLANT WAS NOT COMPRESSED ENOUGH FOR PROPER IMPLANT LOCKING. A REVISION IS SCHEDULED TO REPLACE THE UNLOCKED IMPLANT. NO PATIENT HARM IS NOTED.

Additional Manufacturer Narrative

THE CHALLENGING ANATOMY PROHIBITED THE DEVICE FROM BEING ADEQUATELY COMPRESSED AND LOCKED. NO PATIENT HARM WAS NOTED. MEDICAL INTERVENTION WAS REQUIRED TO AVOID SERIOUS INJURY.