BIA-GEN Bioactive CS-MCCBA-400Recalls & reported problems
Collagen Matrix, Inc. · Moldable Bone Graft Matrix · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813954024134), received between Feb 24, 2023 and Feb 24, 2023 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Myalgia1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
COMPLAINT WAS REPORTED FROM A CLINICAL SITE THAT COLLAGEN MATRIX, INC. IS CURRENTLY COLLECTING DATA FROM. BIA-GEN BIOACTIVE MOLDABLE (STRIP) WAS USED ON PATIENT. PATIENT HAD SURGERY FOR TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AND POSTERIOR INSTRUMENTED FUSION FOR THE TREATMENT OF HIGH-GRADE ANTEROLISTHESIS ON (B)(6) 2021. PATIENT RETURNED FOR CLINICAL FOLLOW-UP VISIT 9 MONTHS POST SURGERY ON (B)(6) 2023 AND REPORTED COMPLETE IMPROVEMENT OF SPINE SYMPTOMS THAT SHE HAD BEFORE THE SURGERY. PATIENT CONFIRMED SHE "IS HAPPY WITH THE SURGICAL OUTCOMES." HOWEVER, PATIENT COMPLAINED OF HIP PAIN (WORSENED BY AMBULATION) AND GENERALIZED MUSCLE PAIN OVER THE CERVICOTHORACIC MIDLINE REGION (WORSENED BY PALPATION AND SOMETIMES EDEMATOUS). PATIENT STATED STANDING FOR TOO LONG AND SITTING FOR TOO LONG "MAKES IT WORSE." HEAT AND IBUPROFEN "MAKE IT BETTER." THE LUMBAR SPINE X-RAYS SHOWED COMPLETE REDUCTION OF THE L4-5 HIGH-GRADE ANTEROLISTHESIS AND THE L3-L5 HARDWARE IS WELL-POSITIONED WITH NO SIGNS OF FAILUTRE. COMPLAINANT CONFIRMED NO FURTHER TREATMENT REGARDING THE SPINE SURGERY IS NEEDED. PATIENT WAS REFERRED TO PHYSIATRY TO ASSESS MUSCLE PAIN AND HIP PAIN. THERE WAS NO FURTHER INFORMATION
Patient problems: Myalgia; Pain
MAUDE report 16436322 ↗
Other Filler, Bone Void, Calcium Compound devices
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44150Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND3 recalls1 report
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42275Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls1 report
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42280Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42200Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44145Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- MAGNIFUSE® Bone Graft 7509014Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall2 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T43102Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall2 reports
- HydroSet XT 897005Stryker Corporation · FILLER, BONE VOID, CALCIUM COMPOUND1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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