BioCORE 214-0120-STRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00813954024776), received between Jun 6, 2025 and Jul 17, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 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. BIOCORE MOLDABLE BIOACTIVE GRAFT WAS USED IN A PATIENT FOR POSTEROLATERAL SPINE SURGERY ON (B)(6) 2024. THE GRAFT WAS PLACED IN VERTEBRAE LOCATIONS 3-4, 4-5 AND 5-S1 AND MIXED WITH BONE MARROW ASPIRATE AND AUTOGRAFT (NOT COLLAGEN MATRIX, INC. PRODUCTS). A CAGE AND INVICTUS SCREWS (NOT COLLAGEN MATRIX, INC. PRODUCTS) WERE ALSO USED IN CONJUNCTION WITH THE BIOCORE PRODUCT DURING THE INITIAL SURGERY. CUSTOMER STATED THE BIOCORE PRODUCT HANDLED AND PERFORMED EXCELLENT, AND THERE WERE NO NOTABLE COMPLICATIONS OBSERVED DURING IMPLANTATION. AT A ROUTINE 6-WEEK FOLLOW-UP VISIT ON (B)(6) 2024, THE PATIENT REPORTED NO PAIN IN THEIR BACK OR LEGS. THE SPINAL FUSION BASED OFF RADIOGRAPH WAS CLASSIFIED AS SATISFACTORY. NO OTHER CONCOMITANT MEDICAL TREATMENTS WERE NOTED AND THERE WERE NO COMPLICATIONS OR ADVERSE EVENTS REPORTED AT THIS FOLLOW-UP VISIT. AT A ROUTINE 3-MONTH FOLLOW-UP VISIT ON (B)(6) 2025, PATIENT REPORTED PAIN IN THE LOWER BACK BUT NO PAIN IN EITHER LEG. THE SPINAL FUSION ASSESSMENT BASED ON RADIOGRAPH MAIN

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

  MAUDE report 22532890 ↗
• InjuryJul 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED AND IT IS UNLIKELY ADDITIONAL INFORMATION WILL BE PROVIDED. TWO BIOCORE PRODUCTS (DIFFERENT ITEM NUMBERS AND DIFFERENT LOT NUMBERS) WERE USED ON A PATIENT FOR POSTEROLATOERAL SPINAL SURGERY ON (B)(6) 2025. BIOCORE PRODUCTS WERE IMPLANTED IN LOCATIONS L3-L4 AND L4-L5 OF THE VERTEBRAE AND MIXED WITH BONE MARROW ASPIRATE AND AUTOGRAFT (NOT COLLAGEN MATRIX, INC. PRODUCTS). RODS, INVICTUS SCREWS, AND TWO CAGES WERE ALSO USED (NOT COLLAGEN MATRIX, INC. PRODUCTS). CUSTOMER CONFIRMED THERE WERE NO COMPLICATIONS NOTED DURING IMPLANTATION AND THE BIOCORE PRODUCTS HANDLED EXCELLENT. AT A 6-WEEK FOLLOW-UP APPOINTMENT ON (B)(6) 2025, AN ADVERSE EVENT OF SYSTEMIC WEIGHT LOSS WAS REPORTED, IN WHICH THE HAD A LOSS OF APPETITE AFTER SURGERY WITH SUBSEQUENT WEIGHT LOSS OF 28 POUNDS IN 6 WEEKS. THE PATIENT WAS REFERRED FOR A GASTRO ENTEROLOGIST CONSULTATION. THE FOLLOWING INTERVENTION TYPES WERE NOTED: ADD PROTEIN SHAKES TO THEIR DIET, KEEP A CALORIE COUNT, AND POSSIBLE THERAPY SESSIONS. NO FURTHER DETAILS SURROUNDING PATIENT OUTCOME OR PATIENT STATUS WILL BE PROVIDED.

  Patient problems: Weight Changes

  MAUDE report 22418876 ↗
• InjuryJul 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED AND IT IS UNLIKELY ADDITIONAL INFORMATION WILL BE PROVIDED. TWO BIOCORE PRODUCTS (DIFFERENT ITEM NUMBERS AND DIFFERENT LOT NUMBERS) WERE USED ON A PATIENT FOR POSTEROLATOERAL SPINAL SURGERY ON (B)(6) 2025. BIOCORE PRODUCTS WERE IMPLANTED IN LOCATIONS L3-L4 AND L4-L5 OF THE VERTEBRAE AND MIXED WITH BONE MARROW ASPIRATE AND AUTOGRAFT (NOT COLLAGEN MATRIX, INC. PRODUCTS). RODS, INVICTUS SCREWS, AND TWO CAGES WERE ALSO USED (NOT COLLAGEN MATRIX, INC. PRODUCTS). CUSTOMER CONFRIMED THERE WERE NO COMPLICATIONS NOTED DURING IMPLANTATION AND THE BIOCORE PRODUCTS HANDLED EXCELLENT. AT A 6-WEEK FOLLOW-UP APPOINTMENT ON (B)(6) 2025, AN ADVERSE EVENT OF SYSTEMIC WEIGHT LOSS WAS REPORTED, IN WHICH THE HAD A LOSS OF APPETITE AFTER SURGERY WITH SUBSEQUENT WEIGHT LOSS OF 28 POUNDS IN 6 WEEKS. THE PATIENT WAS REFERRED FOR A GASTRO ENTEROLOGIST CONSULTATION. THE FOLLOWING INTERVENTION TYPES WERE NOTED: ADD PROTEIN SHAKES TO THEIR DIET, KEEP A CALORIE COUNT, AND POSSIBLE THERAPY SESSIONS. NO FURTHER DETAILS SURROUNDING PATIENT OUTCOME OR PATIENT STATUS WILL BE PROVIDED.

  Patient problems: Weight Changes

  MAUDE report 22418759 ↗
• InjuryJun 7, 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 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 PHYSIC

  Patient problems: Pain

  MAUDE report 22162449 ↗
• 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 22162112 ↗