FILLER, BONE VOID, CALCIUM COMPOUND

Description of Event or Problem

PROVIDENCE WAS CONTACTED BY A PATIENT WHO UNDERWENT A THREE-LEVEL STANDALONE PROCEDURE AT L3-L4, L4-L5, AND L5-S1 WITH ALLOGRAFT ON (B)(6) 2026. ACCORDING TO THE PATIENT, THE ALLOGRAFT MIGRATED INTO THE FASCIA FOLLOWING THE PROCEDURE, RESULTING IN AN INFECTION THAT REQUIRED A WASHOUT PROCEDURE IN EARLY (B)(6) 2026. THE PATIENT REPORTED THAT THE ALLOGRAFT MIGRATION WAS ATTRIBUTED TO SPONDYLOLISTHESIS AT THE TREATED LEVELS. PROVIDENCE DID NOT PROVIDE THE ALLOGRAFT PRODUCT USED IN THE CASE. THE REPORTED INFORMATION WAS SHARED WITH THE SURGEON AND SALES REPRESENTATIVE FOR FOLLOW-UP. OUT OF AN ABUNDANCE OF CAUTION, PROVIDENCE HAS SUBMITTED THIS EVENT AS AN MDR, ALTHOUGH THE REPORTED ISSUE WAS DETERMINED NOT TO BE RELATED TO OUR PRODUCTS.