IDENTITI ANTERIOR LUMBAR POROUS TI INTERBODY SYSTEM

Additional Manufacturer Narrative

H3. YES, H6. INVESTIGATION FINDINGS: 3252. INVESTIGATION CONCLUSIONS: 61. DEVICE EVALUATION: VISUAL INSPECTION CONFIRMS THE COMPLAINT. ONE OF THE PADDLES OF ONE DISTRACTOR ARM FRACTURED OFF. THE BUTTON SPRING WAS NOT RETURNED. THE ROOT CAUSE IS LIKELY THAT THE INSTRUMENT WAS TWISTED WHILE ATTEMPTING TO DISTRACT THE DISC SPACE CAUSING EXCESS LOAD FROM THIS TORSION AND BENDING. REVIEW OF DEVICE HISTORY RECORDS SHOWED NO MANUFACTURING OR PROCESSING RELATED IRREGULARITIES. LABELING REVIEW: WARNINGS/CAUTIONS/PRECAUTIONS: POTENTIAL RISKS IDENTIFIED WITH THE USE OF THESE FUSION DEVICES, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE DEVICE COMPONENT FAILURE, LOSS OF FIXATION, PSEUDARTHROSIS (I.E., NON-UNION), FRACTURE OF THE VERTEBRA, NEUROLOGICAL INJURY, AND/OR VASCULAR OR VISCERAL INJURY. POSSIBLE ADVERSE EFFECTS: INITIAL OR DELAYED LOOSENING, BENDING, DISLOCATION, AND/OR BREAKAGE OF DEVICE COMPONENTS. PHYSIOLOGICAL REACTION TO IMPLANT DEVICES DUE TO FOREIGN BODY INTOLERANCE INCLUDING INFLAMMATION, LOCAL TISSUE REACTION, SEROMA, AND POSSIBLE TUMOR FORMATION.

Additional Manufacturer Narrative

THE DEVICE IS CURRENTLY BEING EVALUATED. A FOLLOW-UP REPORT WITH THE RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON COMPLETION.

Description of Event or Problem

IT WAS REPORTED THE DISTAL END OF THE DISTRACTOR BROKE OFF. NO PATIENT INVOLVEMENT WAS REPORTED.