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OssiMend Bioactive Moldable MCCBA1006Recalls & reported problems

Collagen Matrix, Inc. · Moldable Bone Graft Matrix · Class 2 · Implant

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 00813954022932), received between Sep 1, 2022 and Sep 1, 2022 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Hematoma1

Recent adverse event reports

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

  • InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    BIOACTIVE MINERAL COLLAGEN COMPOSITE WAS USED ON PATIENT FOR LUMBAR STENOSIS/LAMINECTOMY PROCEDURE ON (B)(6) 2022. ON (B)(6) 2022, PATIENT RETURNED TO THE ER AND REPORTED THAT HE HAD WORSENING BACK PAIN, LEG PAIN, ASSOCIATED WEAKNESS, AND WAS UNABLE TO URINATE. PATIENT ALSO REPORTED HAVING TROUBLE STANDING, WALKING, AND GETTING DRESSED THE NIGHT PRIOR TO RETURNING TO THE ER. INTERVENTION SURGERY WAS REQUIRED TO TREAT LARGE HEMATOMA AT SITE OF LUMBAR PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED ON PATIENT STATUS OR PATIENT OUTCOME.

    Patient problems: Hematoma

    MAUDE report 15341391 ↗

Other Filler, Bone Void, Calcium Compound devices

All Filler, Bone Void, Calcium Compound devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.