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SYMBIOS 32310001Recalls & reported problems

Collagen Matrix, Inc. · Xenograft Granules, Particle Size 0.25-1.0mm · 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 M440323100010), received between Jan 5, 2017 and Jan 5, 2017 — 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

  • Fibrosis1

Recent adverse event reports

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

  • InjuryJan 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REPORT OF EXUBERANT GROWTH OF BULBOUS, FIBROUS MASS OVER THE EXTRACTION SITE WAS RECEIVED, THE MASS WAS EXCISED AND SUBMITTED FOR HISTOPATHOLOGICAL EVALUATION BY THE CLINICIAN. COLLAGEN MATRIX, INC. HAS NOT RECEIVED THE EVALUATION RESULTS FROM THE REPORTING CLINICIAN. THE PRODUCT WAS LEFT IN PLACE AND THE PATIENT WAS DOING WELL AT THE TIME OF REPORTING.

    Patient problems: Fibrosis

    MAUDE report 6227247 ↗

Other Bone Grafting Material, Animal Source devices

All Bone Grafting Material, Animal Source devices →

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