AUGMENT® Injectable K30003010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10859477002140), received between May 26, 2021 and Dec 10, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (4 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY FOR UNKNOWN REASONS AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 23769564 ↗
• MalfunctionSep 23, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE KIT HAD 1.5CC RHPDGF VIAL INSTEAD OF THE 3CC RHPDGF VIAL. THE KIT WAS MIXED AND COMBINED WITH A SECOND UNIT OF 1.5CC TO GET THE 3CC TOTAL. THIS WAS COMBINED WITH AN ADDITIONAL 3CC KIT AS THE SURGEON WANTED 6CC IN TOTAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518282 ↗
• MalfunctionSep 22, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE SURGEON REQUESTED A 3CC OF RHPDGF AND THE VIAL ONLY HAD 1.5CC OF LIQUID. THIS MADE THE MIXING REALLY HARD. THERE WAS APPROXIMATELY A 15MINUTES DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12516747 ↗
• MalfunctionSep 22, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE KIT HAD 1.5CC RHPDGF VIAL INSTEAD OF THE 3CC RHPDGF VIAL. THE KIT WAS MIXED AND COMBINED WITH A SECOND UNIT. NO IMPACT TO PATIENT, JUST LESS PRODUCT USED THAN PLANNED. NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12516746 ↗
• MalfunctionSep 2, 2021Clumping in Device or Device Ingredient; Clumping in Device or Device Ingredient

  IT WAS REPORTED THAT THE SURGEON ASKED FOR A 3CC KIT. ONE WAS BROUGHT INTO THE ROOM. THE PREMIX PROCEDURE WAS FOLLOWED. THE MATERIAL DID NOT RECONSTITUTE CORRECTLY, IT REMAINED ALMOST LIKE A POWDER AFTER THE FLUID WAS MIXED. SURGEON WAS UNABLE TO USE THE GRAFT AS IT WOULD NOT HOLD IN PLACE IN THE JOINT. ANOTHER 3CC KIT WAS NOT IN HOUSE SO TWO 1.5CC GRAFTS WERE USED AND RECONSTITUTED. BOTH OF THEM RECONSTITUTED JUST FINE AND WERE ABLE TO UTILIZE THEM. THE SURGEON FELT IT WAS A DEFECT IN PERHAPS THE FLUID OR SOMETHING THAT CAUSED THE FIRST FAILURE TO RECONSTITUTE AND DID NOT WANT THE PATIENT CHARGED FOR THE 3CC GRAFT. 2X 1.5CC AUGMENT INJECTABLE WERE USED. THE IMPACT TO THE PATIENT WAS ADDED TIME UNDER ANESTHESIA AND THEIR EXPENSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418410 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DIABETIC NEUROPATHIC CHARCOT PATIENT UNDERWENT TTC FUSIONAS A LIMB SALVAGE PROCEDURE USING NON-SYK TTC NAIL SYSTEM. SURGEON REPORTS UTILIZING AUGMENT INJ & VIVIGEN BELLULAR ALLOGRAFT IN INDEX PROCEDURE. AT APPROXIMATELY 3 MONTHS POST-IMPLANTATION, RADIOGRAPHIC IMAGING INDICATED EVIDENCE OF INADEQUATE BONE FORMATION IN TREATED JOINTS, FURTHER DETERIORATION OF OVERALL HINDFOOT BONE STOCK (CHARCOT-MARIE TOOTH DISEASE) AND LOOSENING OF SCREW IN TTC NAIL, AND A REVISION SURGERY WAS SCHEDULED. REVISION SURGERY WAS PERFORMED AS SCHEDULED ON (B)(6) 2021 DURING WHICH IGNITE AND INFUSE BONE GRAFT WERE IMPLANTED, AND THE LOOSED SCREW WAS REMOVED AND REPLACED. NO OTHER ADVERSE IMPACTS TO THE PATIENT WERE REPORTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12406704 ↗
• MalfunctionMay 26, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE PACKAGE HAD A 1.5CC VIAL INSTEAD OF THE 3CC VIAL. THE PRODUCT WAS DIFFICULT TO MIX BECAUSE OF THE RATION OF LIQUID TO BBTCP. THE SURGEON WAS ABLE TO INJECT AT THE SITE WITH NO PATIENT COMPLICATIONS REPORTED. THERE WAS NO BACKUP KIT AVAILABLE. NO IMPACT TO PATIENT, JUST LESS PRODUCT USED THAN PLANNED. NO DELAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886004 ↗