BIA-GEN Bioactive CS-MCCBA-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813954024127), received between Feb 24, 2023 and Feb 24, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  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 L4-5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) ON (B)(6) 2022. ONE MONTH AFTER THE SURGERY, PATIENT WAS AT HOME AND FELT A SENSATION OF HEAT THROUGHOUT HIS WHOLE BODY AND FAINTED, STRIKING HIS HEAD ON (B)(6) 2022. PATIENT'S BACK PAIN GOT WORSE. THE PATIENT ADMITTED HIMSELF TO THE EMERGENCY DEPARTMENT ON (B)(6) 2022, COMPLAINING OF LEFT-SIDED BACK PAIN THAT IS NEW SINCE THE BACK SURGERY PROCEDURE. PATIENT DESCRIBES THE BACK PAIN "AS SHARP, RADIATING DOWN THE LEFT LEG." THE PAIN IS INTERMITTENTLY RELIEVED WITH PERCOCET. PATIENT ALSO HAS EXPERIENCED WEAKNESS/PAIN IN THE LATERAL PORTION OF HIS LEFT LOWER EXTREMITY. PATIENT CONFIRMED THERE HAVE BEEN NO FURTHER FAINTING EPISODES AND CONFIRMED THERE HAS BEEN NO CHEST PAIN OR PALPITATIONS. EMERGENCY DEPARTMENT PHYSICIAN CONFIRMED PATIENT DID NOT EXHIBIT FOCAL WEAKNESSES AND PATIENT IS AMBULATING WITH STEADY GAIT. PHYSICIAN ATTRIBUTES SYNCOPE EPISODE TO LIKELY BE ORTHOSTATIC VERSUS VASOVAGAL. THE LUMBAR SITE OF RECENT SURGERY WAS WELL-APPEARING WITH INTA

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

  MAUDE report 16436619 ↗