DBM Putty 5.0cc, Axograft X090-0015-PT5CCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849777005661), received between Sep 14, 2017 and Sep 14, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Shelf Life Exceeded” (1 report).

1 other recall cover devices cleared under the same FDA submission (K130498); they may or may not involve this specific model.

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.

• MalfunctionSep 14, 2017Shelf Life Exceeded; Shelf Life Exceeded

  ON (B)(4) 2017 BACTERIN WAS NOTIFIED OF AN EXPIRED DBM PUTTY GRAFT IMPLANT. THE GRAFT WAS SOLD AND DISTRIBUTED TO A PRIVATE LABEL DISTRIBUTOR ON 11/02/2015. THE PRIVATE LABEL DISTRIBUTOR SHIPPED THE GRAFT TO THE END-USER FACILITY ON 11/23/2015. THE GRAFT EXPIRED ON 12/03/2016, AND THEN WAS IMPLANTED ON (B)(6) 2017. AT THE TIME OF THIS REPORT THERE WERE NO KNOWN COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6866780 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130498. One submission often covers many models, so check the product and lot details in each record.

• Z-1526-2020 · May 3, 2019 · Terminated
  OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Produc