BIO DBM 7775001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327177374), received between Oct 27, 2016 and Oct 27, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Expiration Issue” (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.

• MalfunctionOct 27, 2016Device Expiration Issue

  IT WAS REPORTED THAT; DURING A ONE LEVEL MIS TLIF CASE WITH DOCTOR, HE REQUESTED A 2 OR 3 CC 'S OF DBM AVAILABLE TO MIX WITH HIS AUTOGRAFT SO AS THE CASE BEGAN FOUR BOXES OF 1 CC BIO DBM WERE BROUGHT FROM WHERE IT IS STORED AT THE HOSPITAL. WE GOT TO THE POINT WHERE WE NEEDED TO OPEN GRAFT AND TWO 1CC BIO DBM GRAFTS WERE REQUESTED TO OPEN TO THE FIELD. RANDOMLY GRABBED TWO BOXES OUT OF THE FOUR IN THE ROOM AND HANDED THEM TO CIRCULATOR TO OPEN. I THEN LEFT THE ROOM TO GO GRAB CAGES TO BRING IN. BY THE TIME I GOT BACK THE GRAFT WAS OPEN AND ON THE FIELD. I PUT STICKERS ON MY CHARGE SHEET AND CONTINUED WITH THE CASE. I DID NOT OPEN, OR LOG INTO THE HOSPITAL TISSUE TRACKING BOOK ANY OF THE TRACKING INFORMATION. I WAS NOTIFIED THAT ONE OF THE GRAFTS WE USED WAS EXPIRED ON 9/15/16.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6062016 ↗