CONFORM BINDER SUBMALAR (R)

Additional Manufacturer Narrative

EVALUATION SUMMARY ATTACHED: METHOD: THE ACTUAL DEVICE WAS NOT EVALUATED, HOWEVER MANUFACTURING RECORDS WERE REVIEWED AND LABELING WAS EVALUATED. RESULTS: NO FAILURE WAS DETECTED. CONCLUSION: THE REPORTED EVENTS ARE KNOWN INHERENT RISKS OF THE PROCEDURE. PRODUCT LABELING ADDRESSES THE POSSIBILITY OF EXTRUSION, AS WELL AS OTHER COMPLICATIONS ASSOCIATED WITH ALL SURGICAL PROCEDURES, INCLUDING HEMATOMA.

Description of Event or Problem

COMPLAINANT REPORTED THAT PATIENT HAD MALAR IMPLANTS EXPLANTED ONE WEEK POST-OPERATIVELY DUE TO BILATERAL EXTRUSION AND HEMATOMA.