FIBERGRAFT BG Matrix 5500-0125Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00856879006151), received between Nov 26, 2019 and Feb 28, 2023 — classified as 1 injury, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO THE MANUFACTURER ON (B)(6) 2023 THAT THE PRODUCT WAS IMPLANTED IN THE LATERAL GUTTERS IN THE PATIENT ON A T8-ILIUM POSTERIOR FUSION ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT PRESENTED WITH A SEVERE INFECTION IN THE POSTERIOR LATERAL GUTTERS. THE SURGEON REMVOED ALL THE PRODUCT IN THE POSTERIOR LATERAL GUTTERS AND WASHED OUT THE AREA. THE PATIENT WAS BROUGHT BACK FOR WASH OUT TWO MORE TIMES, ON (B)(6) 2022 AND (B)(6) 2022. ALL THE SCREWS, RODS, AND SET SCREWS IMPLANTED ALONG WITH THE PRODUCT ON (B)(6) 2022 REMAINED IN THE PATIENT.

  Patient problems: Unspecified Infection

  MAUDE report 16454597 ↗
• MalfunctionNov 26, 2019No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2019, (B)(+) WAS USED IN A TRAUMA PROCEDURE AND IMPLANTED IN A PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. AFTER THE PROCEDURE WAS COMPLETED, THE COMPANY WAS INFORMED THAT THE PRODUCT WAS USED PAST ITS LABELLED EXPIRY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9379164 ↗