BioCORE 214-0060-STRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813954024769), received between May 8, 2024 and Jun 6, 2025 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 WAS DIAGNOSED WITH CHRONIC LOWER BACKPAIN. TWO ITEMS OF THE BIOCORE MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE WERE USED ON A PATIENT DURING INITIAL SURGERY ON (B)(6) 2024. PRODUCT WAS IMPLANTED IN PATIENT IN LOCATION L3-4 AND L4-5. A BONE MARROW ASPIRATE AND ALLOGRAFT (NOT COLLAGEN MATRIX, INC. PRODUCTS) WERE USED IN CONJUNCTION WITH THE BIOCORE BIOACTIVE PRODUCT. ADDITIONALLY, IT WAS REPORTED THAT INVICTUS SCREWS AND A CAGE WAS ALSO USED (NOT COLLAGEN MATRIX, INC. PRODUCTS). CUSTOMER REPORTED NO COMPLICATIONS WERE NOTED DURING IMPLANT AND THE PRODUCT HANDLED AND PERFORMED EXCELLENT. ON (B)(6) 2024 THERE WAS MILD ANTERIOR SUBSIDENCE OF THE L4-L5 CAGE INTO THE ANTERIOR L5 VERTEBRAL BODY. CUSTOMER CONFIRMED THIS WAS NOT A SERIOUS ADVERSE EVENT AND REPORTED PHYSICAL THERAPY AS THE BEHAVIORAL/LIFESTYLE INTERVENTION FOR THE PATIENT. CUSTOMER STATED PATIENT WAS TO START PHYSICAL THERAPY ON (B)(6) 2024. NO FURTHER DETAILS SURROUNDING OUTCOME OF PHYSICAL THERAPY, PATIENT STATUS, AND PATIENT OUTCOME WILL

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22162085 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT WAS RECEIVED THROUGH A CLINICAL DATA COLLECTION. PATIENT DIAGNOSED WITH SPONDYLOLISTHESIS (LUMBAR REGION) AND LUMBAR SPINAL STENOSIS. THE CUSTOMER REPORTED THE BIOCORE PRODUCT WAS USED FOR A POSTEROLATERAL SPINE PROCEDURE ON (B)(6) 2024. TWO ITEM NUMBERS OF BIOCORE PRODUCT WERE PROVIDED BY THE CUSTOMER AND CONFIRMED TO BE USED ON THE PATIENT AT THE SAME TIME FOR THE PROCEDURE. THE BIOCORE PRODUCT WAS IMPLANTED AT VERTEBRAE SITES 3-4 AND 4-5, HOWEVER IT WAS NOT SPECIFIED WHICH PRODUCT WAS UTILIZED AT WHAT VERTEBRAE SITE. THE BIOCORE PRODUCT WAS MIXED WITH BONE MARROW ASPIRATE. ATEC SCREWS AND EXPANDABLE CAGES WERE ALSO USED DURIGN THE PROCEDURE - ONLY THE BIOCORE PRODUCTS ARE MANUFACTURED BY COLLAGEN MATRIX, INC. THE PATIENT'S L3-L4 INTERBODY CAGE HAS BEEN DISPLACED POSTERIORLY, CONFIRMED BY RADIOGRAPHS TAKEN ON (B)(6) 2024. THE INTERBODY CAGE THAT WAS DISPLACED IS NOT MANUFACTURED BY COLLAGEN MATRIX, INC. DURING THE (B)(6) 2024 FOLLOW-UP VISIT THE PATIENT WAS REPORTED TO BE "DOING EXTREMELY WELL POSTOPERATIVELY." NO SIGNIFICANT PAIN REPORTED. THE PATIENT HAD REVISION SURGERY PERFORMED ON (B)(6) 2024. REVISION SURGERY CONSISTED OF THE FOLLOWING SURGERIES: (1) EXPLORATION O

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19271481 ↗