INFINITY

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A FIELD CONTACT REGARDING A PATIENT WITH AN UNKNOWN INDICATION FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SURGEON WAS USING DRILL BIT IN THE C1 VERTEBRAE AND THE DRILL BIT FRACTURED AND REMAINED LODGED IN THE C1 VERTEBRAE. THE PATIENT DOES NOT SEEM TO HAVE ANY ADVERSE ISSUES CURRENTLY, HOWEVER, THE SURGEON HAS CONCERNS REGARDING THE DRILL BIT FRAGMENT DISLODGING IF THE PATIENT EVER REQUIRES AN MRI. UNABLE TO DETERMINE THE RETURN STATUS BUT THE PRODUCT WAS REPLACED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD CONTACT. PROCEDURE: C1-C2 POSTERIOR FUSION PRE-OPERATIVE DIAGNOSIS: CHRONIC ODONTOID FRACTURE WITH SPINAL CORD INJURY THE FRAGMENT IS STILL LODGED IN THE BODY OF C1. NO KNOWN SYMPTOMS OR COMPLICATIONS CURRENTLY, HOWEVER, THE SURGEON IS CONCERNED IT MIGHT NOT ME ANCHORED ENOUGH IN THE BONE AND IS WORRIED THAT IT COULD COME DISLODGED DURING AN MRI. THE SURGEON HAS PROPOSED REMOVAL OF THE FRAGMENT IN A YEAR WHEN THE PATIENT HAS ESTABLISHED A FUSION AT THE C1-C2 LEVEL. THE REMAINING PORTION OF THE DRILL BIT THAT IS NOT IN THE PATIENT IS CURRENTLY IN THE POSSESSION OF RISK MANAGEMENT AT MEDICAL CENTER OF THE ROCKIES.