Description of Event or Problem · 0
COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED AND IT IS UNLIKELY FURTHER INFORMATION SURROUNDING THE PATIENT OR THE EVENT WILL BE PROVIDED. PATIENT REPORTED TO BE DIAGNOSED WITH LUMBAR SPONDYLOSIS WITH RADICULOPATHY. THE BIOCORE MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE PRODUCT WAS USED ON A PATIENT DURING POSTEROLATOERAL SPINAL SURGERY ON (B)(6) 2024. PRODUCT WAS IMPLANTED IN VERTEBRAE LOCATION 3-4 AND 4-5. THE BIOCORE PRODUCT WAS MIXED WITH BONE MARROW ASPIRATE AND AUTOGRAFT (NOT COLLAGEN MATRIX, INC. PRODUCTS). ATEC INVICTUS MODULAR SCREWS WERE ALSO USED DURING THIS PROCEDURE (NOT MANUFACTURED OR DISTRIBUTED BY COLLAGEN MATRIX, INC.). CUSTOMER REPORTED THERE WERE NO COMPLICATIONS NOTED DURING PRODUCT IMPLANT AND THE PRDOUCT HANDLED AND PERFORMED EXCELLENT. ON 05/30/2024, IT WAS REPORTED PATIENT EXHIBITED LEFT SHOULDER IMPINGEMENT SYNDROME, WHERE THE PATIENT REPORTED LEFT SHOULD PAIN LOCALIZED IN THE LEFT SHOULDER BLADE REGION. CUSTOMER STATED THIS WAS NOT AN UNEXPECTEED ADVERSE EVENT NOR WAS IT A SERIOUS ADVERSE EVENT. THE PATIENT HAD AN "ORTHO CONSULT" FOLLOWED BY AN INTERVENTION METHOD OF PHYSICAL THERAPY. PATIENT PARTICIPATED IN PHYSICAL THERAPY TO TREAT THE REPORTED ADVERSE EVENT. CUSTOMER NOTED THE ADVERSE EVENT STOP DATE WAS (B)(6) 2025, AND THE REPORTED EVENT WAS NOT RELATED TO THE INTERVENTION (PHYSICAL THERAPY) REQUIRED. NO FURTHER DETAILS SURROUNDING OUTCOME OF PHYSICAL THERAPY, PATIENT STATUS, OR PATIENT OUTCOME WILL BE PROVIDED.