BIO DBM 7775010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327177398), received between Apr 26, 2017 and Apr 26, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2017Device Damaged Prior to Receipt by User; Adverse Event Without Identified Device or Use Problem; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT; DR. BOOKED LUMBAR FUSION AND SAID MUST USED DBM PUTTY. WE ORDERED DBM PUTTY LAST WEEK FOR CASE BUT THE 10CC PUTTY WE ORDERED WAS ON B/O SO WE DIDN'T RECEIVE THAT. WE HAD 20CC TOTAL (5CC SIZE), SO AS A BACK UP WE HAD A COURIER BRING 10CC PUTTY FROM (B)(6) THE MORNING OF (B)(6) 2017. AS THE CASE WENT ON WE OPENED ALL 5CC SIZES AND DR. SAID HE NEEDED MORE SO THEN THE BORROWED 10CC WAS OPENED FOR CASE. THIS WAS DONE SO BEFORE THE HOSPITAL COULD INPUT THE PRODUCT IN THEIR SYSTEM. LATER ON IN DAY WE GOT A CALL FROM HOSPITAL ASKING WHERE WE GOT THE DBM FROM. REP EXPLAINED HOW WE GOT THE PRODUCT, THAT A PIECE OF TISSUE WAS TRANSFERRED FROM ONE HOSPITAL TO ANOTHER.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6522682 ↗