GRAFTON MATRIX PLF

Description of Event or Problem

DURING AN L4-L1 FUSION, THE SURGEON PLACED DBM BONE VOID FILLER INSIDE THE PEEK CAGE AS WELL AS IN THE DISC SPACE ANTERIOR TO THE CAGE. AT FOUR WEEKS POST-OP, THE CAGE HAD MIGRATED POSTERIORLY. A REVISION PROCEDURE WAS PERFORMED IN WHICH THE DBM GRAFT MATERIAL WAS REMOVED FROM THE CAGE AND THE DISC SPACE AND THE CAGE WAS REPOSITIONED USING AUTOGRAFT.

Additional Manufacturer Narrative

MFG RECORDS WERE REVIEWED AND INDICATED THAT THE SUBJECT LOT OF PRODUCT WAS MANUFACTURED PER PROCEDURE AND MET ALL REQUIRED SPECIFICATIONS AND RELEASE CRITERIA. ALL CRITICAL PROCESSING PARAMETERS WERE MET DURING THE MFG OF THE PRODUCT, AND THERE WERE NO IRREGULARITIES ASSOCIATED WITH MFG. NEITHER THE DEVICE NOR ANY FILMS OF APPLICABLE IMAGING STUDIES WERE PROVIDED BY THE INITIAL RPTR. THE DEFINITIVE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED.