BIA-GEN Bioactive CS-MCCBA-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00813954024110), received between Jun 10, 2025 and Jan 9, 2026 — classified as 1 death, 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED AND IT IS UNLIKELY FURTHER INFORMATION SURROUNDING THE PATIENT OR EVENT WILL BE PROVIDED. TWO BIA-GEN PRODUCTS (DIFFERENT LOT NUMBERS) WERE USED. BIA-GEN WAS USED IN A POSTEROLATOERAL SPINE (LOCATION (L2 TO L5) SURGERY ON (B)(6) 2025. THERE ARE FIVE DIFFERENT ADVERSE EVENTS ASSOCIATED WITH THIS PATIENT. ONLY ONE OF THE ADVERSE EVENTS IS CLASSIFIED AS HAVING A POSSIBLE RELATION TO THE INTERVENTION. AT THE 6 MONTH VISIT, THE PATIENT PRESENTED WITH WEAKNESS IN BILATERAL LOWER EXTREMITIES AND MULTIPLE FALLS OVER A WEEK AND A HALF AND 3 DAYS OF WORSENING BACK PAIN WITH NUMBNESS AND TINGLING. MRI LUMBAR SPINE SHOWED DEGENERATIVE CHANGES BUT NO CORD COMPRESSION. IN THE SETTING OF DECONDITIONING FROM RECENT HOSPITAL STAY. THE ADVERSE EVENT ONSET DATE WAS AUGUST 3, 2025. THE RELATIONSHIP OF THE EVENT TO INTERVENTION HAS BEEN CATEGORIZED AS "POSSIBLE". THE INTERVENTION INCLUDED OUTPATIENT PHYSICAL THERAPY TO CONTINUE. THE ADVERSE EVENT STOP DATE WAS INDICATED AS (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED URINARY CATHETER DYSFUNCTION. A DIME SIZED CLOT WAS FOUND AND FLUSHED. INTERVENTION INCLUDED LIDO

  Patient problems: Hyperplasia; Muscle Weakness/Atrophy; Syncope/Fainting; Urinary Retention

  MAUDE report 24020708 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED AND IT IS UNLIKELY FURTHER INFORMATION SURROUNDING THE PATIENT OR EVENT WILL BE PROVIDED. TWO BIA-GEN PRODUCTS (DIFFERENT LOT NUMBERS) WERE USED. BIA-GEN WAS USED IN A POSTEROLATOERAL SPINE (LOCATION (L2 TO L5) SURGERY ON (B)(6) 2025. THERE ARE FIVE DIFFERENT ADVERSE EVENTS ASSOCIATED WITH THIS PATIENT. ONLY ONE OF THE ADVERSE EVENTS IS CLASSIFIED AS HAVING A POSSIBLE RELATION TO THE INTERVENTION. AT THE 6 MONTH VISIT, THE PATIENT PRESENTED WITH WEAKNESS IN BILATERAL LOWER EXTREMITIES AND MULTIPLE FALLS OVER A WEEK AND A HALF AND 3 DAYS OF WORSENING BACK PAIN WITH NUMBNESS AND TINGLING. MRI LUMBAR SPINE SHOWED DEGENERATIVE CHANGES BUT NO CORD COMPRESSION. IN THE SETTING OF DECONDITIONING FROM RECENT HOSPITAL STAY. THE ADVERSE EVENT ONSET DATE WAS (B)(6) 2025. THE RELATIONSHIP OF THE EVENT TO INTERVENTION HAS BEEN CATEGORIZED AS "POSSIBLE". THE INTERVENTION INCLUDED OUTPATIENT PHYSICAL THERAPY TO CONTINUE. THE ADVERSE EVENT STOP DATE WAS INDICATED AS (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED URINARY CATHETER DYSFUNCTION. A DIME SIZED CLOT WAS FOUND AND FLUSHED. INTERVENTION INCLUDED LIDOCAI

  Patient problems: Hyperplasia; Muscle Weakness/Atrophy; Syncope/Fainting; Urinary Retention

  MAUDE report 24020707 ↗
• InjuryJul 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT WAS SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED AND IT IS UNLIKELY ADDITIONAL INFORMATION SURROUNDING THE EVENT OR PATIENT WILL BE PROVIDED. PATIENT WENT FOR POSTEROLATERAL SPINE SURGERY ON (B)(6) 2025. TWO UNITS (FROM TWO DIFFERENT LOTS) OF THE BIA-GEN BIOACTIVE MOLDABLE BONE GRAFT MATRIX WERE USED ON THE PATIENT IN VERTEBRAE LOCATION L4-L5. THE BIA-GEN WAS ALSO MIXED WITH AN AUTOGRAFT AND ALLOGRAFT (NOT COLLAGEN MATRIX, INC. PRODUCTS; SPECIFIC PRODUCT INFORMATION NOT PROVIDED). THERE WERE ALSO L2-L5 PEDICLE SCREWS AND RODS USED DURING THE INITIAL PROCEDURE (NOT COLLAGEN MATRIX, INC PRODUCTS). CUSTOMER CONFIRMED THERE WERE NO COMPLICATIONS NOTED DURING IMPLANTATION AND THE PRODUCT PERFORMED EXCELLENT. AT THE SCHEDULED 3-MONTH FOLLOW-UP VISIT, AN UNEXPECTED ADVERSE EVENT WAS REPORTED ON (B)(6) 2025, IN WHICH THE PATIENT WENT OUTSIDE AND HIT HIS HEAD. THE LACERATION SITE BECAME INFECTED. THE CUSTOMER DID NOT CATEGORIZE THIS AS A SERIOUS ADVERSE EVENT. THE PATIENT WAS PRESCRIBED KEFLEX FOR THE INFECTION AND SUTURES AND STAPLES WERE USED TO CLOSE THE LACERATION. THE CUSTOMER CONFIRMED THIS EVENT WAS NOT RELATED TO THE INTERVENTION. NO FURTHER DET

  Patient problems: Unspecified Infection

  MAUDE report 22413170 ↗
• InjuryJul 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT WAS SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED AND IT IS UNLIKELY ADDITIONAL INFORMATION SURROUNDING THE EVENT OR PATIENT WILL BE PROVIDED. PATIENT WENT FOR POSTEROLATOERAL SPINE SURGERY ON (B)(6) 2025. TWO UNITS (FROM TWO DIFFERENT LOTS) OF THE BIA-GEN BIOACTIVE MOLDABLE BONE GRAFT MATRIX WERE USED ON THE PATIENT IN VERTEBRAE LOCATION L4-L5. THE BIA-GEN WAS ALSO MIXED WITH AN AUTOGRAFT AND ALLOGRAFT (NOT COLLAGEN MATRIX, INC. PRODUCTS; SPECIFIC PRODUCT INFORMATION NOT PROVIDED). THERE WERE ALSO L2-L5 PEDICLE SCREWS AND RODS USED DURING THE INITIAL PROCEDURE (NOT COLLAGEN MATRIX, INC. PRODUCTS). CUSTOMER CONFIRMED THERE WERE NO COMPLICATIONS NOTED DURIGN IMPLANTATION AND THE PRODUCT PERFORMED EXCELLENT. AT THE SCHEDULED 3-MONTH FOLLOW-UP VISIT, AN UNEXPECTED ADVERSE EVENT WAS REPORTED ON (B)(6) 2025, IN WHICH THE PATIENT WENT OUTSIDE AND HIT HIS HEAD. THE LACERATION SITE BECAME INFECTED. THE CUSTOMER DID NOT CATEGORIZE THIS AS A SERIOUS ADVERSE EVENT. THE PATIENT WAS PRESCRIBED KEFLEX FOR THE INFECTION AND SUTURES AND STAPLES WERE USED TO CLOSE THE LACERATION. THE CUSTOMER CONFIRMED THIS EVENT WAS NOT RELATED TO THE INTERVENTION. NO FURTHER D

  Patient problems: Unspecified Infection

  MAUDE report 22413168 ↗
• InjuryJun 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED AND IT IS UNLIKELY FURTHER INFORMATION SURROUNDING THE PATIENT OR EVENT WILL BE PROVIDED. THE PRODUCT PART OF DATA COLLECTION IS BIA-GEN¿ BIOACTIVE MOLDABLE BONE GRAFT MATRIX. THE INITIAL SURGERY WAS ON (B)(6) 2022. THE PRODUCT WAS USED IN THE POSTEROLATERAL SPINE IN L-2-3-4. BIA-GEN WAS MIXED WITH ALLOGRAFT AND BMP (ADDITIONAL MATERIALS USED WERE NOT DEFINED IN THE INITIAL COMPLAINT). OTHER PRODUCTS USED IN CONJUNCTION WERE L2-3 TILF CAGE, L2-3-4 PEDICLE SCREWS AND RODS. (CMI DOES NOT MANUFACTURE THESE PRODUCTS). THERE WERE NO COMPLICATIONS DURING IMPLANTATION, NO OTHER CONCOMITANT MEDICAL TREATMENT AND THE OVERALL HANDLING AND PERFORMANCE WERE RATED "4-EXCELLENT". THE ADVERSE EVENT ONSET DATE WAS 06/28/2022. THE PATIENT WENT BACK TO THE EMERGENCY DEPARTMENT COMPLAINING FROM BACK PAIN AND LEG PAIN AND INABILITY TO URINATE. PATIENT WAS READMITTED TO THE HOSPITAL. PATIENT WAS TAKEN TO SURGERY TO TREAT LARGE HEMATOMA AT THE SITE OF THE BACK SURGERY FOR THE LUMBAR FUSION. NO FURTHER INFORMATION SURROUNDING PATIENT STATUS OR PATIENT OUTCOME WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22326933 ↗
• InjuryJun 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED AND IT IS UNLIKELY FURTHER INFORMATION SURROUNDING THE PATIENT OR EVENT WILL BE PROVIDED. PRODUCT PART OF DATA COLLECTION IS BIA-GEN¿ BIOACTIVE MOLDABLE BONE GRAFT MATRIX. TWO PRODUCTS OF BIA-GEN WERE USED ON A PATIENT DURING INITIAL SURGERY. THE INITIAL SURGERY WAS ON (B)(6) 2022. THE PRODUCT WAS USED IN THE POSTEROLATOERAL SPINE IN L2-L3, L3-L4. BIA-GEN WAS MIXED WITH ALLOGRAFT AND AUTOGRAFT (NO SPECIFIC DETAILS ON ALLOGRAFT AND AUTOGRAFT PRODUCTS PROVIDED AND CMI DOES NOT MANUFACTURE OR DISTRIBUTED ALLOGRAFT PRODUCTS). OTHER PRODUCTS USED IN CONJUNCTION WERE EXPANDABLE SPACER 10X28X8-13MM, SCREW, CURVED ROD, LOCKING SCREW (CMI DOES NOT MANUFACTURE THESE PRODUCTS). THERE WERE NO COMPLICATIONS DURING IMPLANTATION, NO OTHER CONCOMITANT MEDICAL TREATMENT AND THE OVERALL HANDLING AND PERFORMANCE WERE RATED "4-EXCELLENT". PATIENT REPORTED POST OPERATIVE PAIN, RIGHT SIDED SCIATICA. THE ADVERSE EVENT ONSET DATE WAS 09/17/2022. THE SUBJECT COMPLAINED OF HAVING RIGHT UPPER LEG NUMBNESS AND PINCHING AND WAS ADVISED BY ON-CALL DOCTOR TO GO TO THE EMERGENCY DEPARTMENT TO RULE OUT A POSSIBLE DEEP VEIN THROMBOS

  Patient problems: Insufficient Information

  MAUDE report 22326932 ↗
• InjuryJun 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED AND IT IS UNLIKELY FURTHER INFORMATION SURROUNDING THE PATIENT OR EVENT WILL BE PROVIDED. PRODUCT PART OF DATA COLLECTION IS BIA-GEN¿ BIOACTIVE MOLDABLE BONE GRAFT MATRIX. THE INITIAL SURGERY WAS ON (B)(6) 2022. TWO PRODUCTS OF BIA-GEN WERE USED ON A PATIENT DURING INITIAL SURGERY.THE PRODUCT WAS USED IN THE POSTEROLATOERAL SPINE IN L2-L3, L3-L4. BIA-GEN WAS MIXED WITH ALLOGRAFT AND AUTOGRAFT (NO SPECIFIC DETAILS ON ALLOGRAFT AND AUTOGRAFT PRODUCTS PROVIDED AND CMI DOES NOT MANUFACTURE OR DISTRIBUTED ALLOGRAFT PRODUCTS). OTHER PRODUCTS USED IN CONJUNCTION WERE EXPANDABLE SPACER 10X28X8-13MM, SCREW, CURVED ROD, LOCKING SCREW (CMI DOES NOT MANUFACTURE THESE PRODUCTS). THERE WERE NO COMPLICATIONS DURING IMPLANTATION, NO OTHER CONCOMITANT MEDICAL TREATMENT AND THE OVERALL HANDLING AND PERFORMANCE WERE RATED "4-EXCELLENT". PATIENT REPORTED POST OPERATIVE PAIN, RIGHT SIDED SCIATICA. THE ADVERSE EVENT ONSET DATE WAS 09/17/2022. THE SUBJECT COMPLAINED OF HAVING RIGHT UPPER LEG NUMBNESS AND PINCHING AND WAS ADVISED BY ON-CALL DOCTOR TO GO TO THE EMERGENCY DEPARTMENT TO RULE OUT A POSSIBLE DEEP VEIN THROMBOSIS

  Patient problems: Insufficient Information

  MAUDE report 22326928 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION SITE. LIMITED INFORMATION PROVIDED. PATIENT UNDERWENT POSTEROLATOERAL SPINAL SURGERY ON (B)(6) 2024. THE BIA-GEN MOLDABLE BONE GRAFT MATRIX PRODUCT WAS PLACED IN VERTEBRAE LOCATION L4-L5. AUOGRAFT AND OTHER HARDWARE (NOT MANUFACTURED OR DISTRIBUTED BY COLLAGEN MATRIX, INC.) WERE USED IN CONJUNCTION WITH THE BIA-GEN PRODUCT. A TLIF AND LAMINECTOMY WERE REPORTED AS OTHER CONCOMITANT MEDICAL TREATMENT. THERE WERE NO COMPLICATIONS NOTED DURING THE INITIAL PROCEDURE AND THE CLINICIAN NOTED THE BIA-GEN PRODUCT PERFORMED AND HANDLED EXCELLENT. ON (B)(6) 2024 DURING A PLANNED FOLLOW-UP VISIT, IT WAS NOTED THE PATIENT FELL (EXACT DETAILS OF FALL NOT SPECIFIED OR PROVIDED), WITH INJURY TO HER LEG AND BACK, AND HAS HAD WORSENING BACK PAIN SINCE FALLING. A CT SCAN AND MRI WAS PERFORMED ON PATIENT, INDICATING LOWER BACK PAIN WITH SOME RADICULAR COMPONENT. THE PATIENT WAS PRESCRIBED MEDICATION (OXYCODONE; DOSAGE NOT SPECIFIED), PHYSICAL THERAPY, AND REST. CLINICIAN NOTED THEY DID NOT CONSIDER THIS TO BE A SERIOUS ADVERSE EVENT, AND THE REPORTED EVENT IS NOT RELATED TO THE BIA-GEN PRODUCT. NO ADDITIONAL INFORMATION SURROUNDING PATIENT STATUS, P

  Patient problems: Back pain

  MAUDE report 22198086 ↗
• DeathJun 12, 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. PATIENT WAS INVOLVED IN A CLINICAL STUDY FOR PSEUDOCLAUDICATION SYNDROME. INITIAL SURGERY WAS PERFORMED ON (B)(6) 2024 UTILIZING THE BIA-GEN BIOACTIVE MOLDABLE BONE GRAFT MATRIX. THE PRODUCT WAS PLACED IN VERTEBRAE LOCATIONS L2-L3-L4-L5. THERE WERE NO OTHER PRODUCTS USED IN CONJUNCTION WITH BIA-GEN DURING THE INITIAL SURGERY AND NO COMPLICATIONS NOTED. THE CLINICIAN NOTED THE PRDOUCT HAD HANDLED AND PERFORMED EXCELLENT. ON (B)(6) 2024, THE PATIENT WENT TO THE EMERGENCY DEPARTMENT FOR EMESIS, LEFT FOOT SWELLING AND EPIGASTRIC DISCOMFORT. PATIENT THEN BECAME PALE, UNRESPONSIVE, AND EXPIRED. CLINICIAN BELIEVES CAUSE OF DEATH TO BE CARDIAC ARREST, HYPOXIC ARREST, OR A MISSED MYOCARDIAL INFRACTION. CLINICIAN STATED THE SERIOUS ADVERSE EVENT IS UNRELATED TO THE BIA-GEN PRODUCT. NO FURTHER INFORMATION SURROUNDING PATIENT INFORMATION AND EVENT WILL BE PROVIDED.

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

  MAUDE report 22197618 ↗
• InjuryJun 11, 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 PREVIOUSLY DIAGNOSED WITH SPINAL STENOSIS. PATIENT PARTICIPATED IN A STUDY IN WHICH THE BIA-GEN BIOACTIVE PRODUCT WAS UTILIZED ON (B)(6) 2023 FOR POSTEROLATOERAL SPINE SURGERY. PRODUCT IMPLANTED IN LOCATION L4-L5. OTHER CONCOMITANT MEDICAL TREATMENT WAS PERFORMED (L4-L5 LAMINECTOMY). BONE MARROW ASPIRATE, AUTOGRAFT AND GLOBUS CREO SCREWS/SABLE TLIF CAGE (NOT MANUFACTURED BY COLLAGEN MATRIX, INC) WERE ALSO UTILIZED WITH THE BIA-GEN PRODUCT FOR THE INITIAL SURGERY. CUSTOMER STATED THE BIA-GEN PRODUCT HANDLED AND PERFORMED EXCELLENT, AND THERE WERE NO NOTABLE COMPLICATIONS NOTED DURING IMPLANTATION. ON A FOLLOW-UP VISIT ON (B)(6) 2024, PATIENT REPORTED PAIN/SWELLING IN THE RIGHT CALF. THE SURGEON SENT THE PATIENT FOR AN ULTRASOUND THAT REVEALED A PARTIALLY OCCLUSIVE DEEP VEIN THROMBOSIS IN THE POPLITEAL VEIN. PATIENT RETURNED TO EMERGENCY DEPARTMENT ON (B)(6) 2024 WITH SHORTNESS OF BREATH AND CHEST PAIN. CT ANGIOGRAM OF THE CHEST WAS PERFORMED AND PATIENT WAS DIAGNOSED WITH PULMONARY THROMBOEMBOLISM. TH

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 22188874 ↗
• InjuryJun 10, 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 PART OF CLINICAL STUDY AS THEY WERE PREVOIUSLY DIAGNOSED WITH SPONDYLOLISTHESE IN THE LUMBAR REGION. PATIENT WAS ALSO HAS A HISTORY OF RIGHT KNEE ARTHRITIS. BIA-GEN BIOACTIVE MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE STRIP PRODUCT WAS USED ON PATIENT FOR AN UNSPECIFIED SURGERY ON (B)(6) 2023. THE SURGERY WAS LIKLEY RELATED TO THE SPONDYLOLISTHESE DIAGNOSIS. IT WAS REPORTED ON (B)(6) 2024 THE PATIENT EXHIBITED RIGHT HIP PAIN IN THE GROIN, LIKELY COMING FROM THE HIP SOCKET. CUSTOMER STATED THIS WAS NOT AN UNEXPECTED ADVERSE EVENT AND DID NOT CONSIDER THIS PAIN TO BE A SEVERE ADVERSE EVENT. THE INTERVENTION RECOMMENDED WAS HIP INJECTION UNDER FLUOROSCOPIC GUIDANCE AND A REFERREL TO TOTAL JOINT SURGERY; IT WAS NOT SPECIFIED WHEN THIS INTERVENTION WAS STARTED OR COMPLETED. AFTER CONSULTATION AND MRI WITH THE TOTAL JOINT SURGERY SPECIALIST (DATE NOT SPECIFIED), THE PATIENT WAS FOUND TO HAVE "MODERATE HIP JOINT ARTHROSIS WITH SUPERIOR LABRAL TEAR AND 8MM CYST OVER THE LATERAL ACETABULUM." PATIENT WA

  Patient problems: Pain

  MAUDE report 22181534 ↗