GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T45010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169123038), received between Aug 1, 2022 and Aug 5, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

13 other recalls cover devices cleared under the same FDA submission (K043048); 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.

Recalls naming this device

1. Sep 26, 2023Class IIOpen, Classified

   Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

   Z-0166-2024 · Root cause: Employee error · Recall details · FDA record ↗

2. Feb 8, 2023Class IIOpen, Classified

   Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

   Z-1329-2023 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryAug 5, 2022Biocompatibility; Biocompatibility

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT POSTERIOR CERVICAL DECOMPRESSION/FUSION C4-7 DUE TO CERVICAL TUMOR (SCHWANOMA) IT WAS REPORTED THAT SURGEON HAD TO TAKE PATIENT BACK TO SURGERY DUE TO A CORD COMPRESSION FROM A FLUID COLLECTION. THE FLUID COLLECTION WASN'T BLOOD OR PUS. IT HAD THE APPEARANCE OF INFLAMMATORY FLUID AND HAD GRAFTON DBM MIXED IN WITH IT. IT IS SUSPECTED THAT THE PATIENT MIGHT HAVE HAD AN ALLERGIC REACTION TO ONE OF THE PROCESSING SOLUTIONS IN DBM (SURFACTANT OR ANTIBIOTICS). IT WAS ONLY MIXED WITH PATIENT OWN BONE. SINCE IT WASN'T A HEMATOMA, INFECTION, OR CSF LEAK, AND SINCE GRAFTON WAS FOUND MIXED IN THE COLLECTION, SURGEON BELIEVES IT WAS LIKELY A RARE ALLERGIC REACTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Hypersensitivity/Allergic reaction; Spinal Cord Injury; Swelling/ Edema

  MAUDE report 15173272 ↗
• InjuryAug 1, 2022Patient-Device Incompatibility

  THE PATIENT UNDERWENT POSTERIOR CERVICAL DECOMPRESSION AND FUSION FOR RESECTION OF A TUMOR. MEDTRONIC GRAFTON PLUS DBM (A STANDARD BONE GRAFT USED IN SPINE SURGERY) WAS USED AS ALLOGRAFT TO SUPPLEMENT THE LOCAL AUTOGRAFT. IT WAS APPLIED TO THE FACET JOINTS IN STANDARD FASHION. THE SPINAL CORD WAS COMPLETELY FREE OF COMPRESSION AT WOUND CLOSURE. A SURGICAL DRAIN WAS PLACED AND REMOVED POSTOP DAY 2 AFTER OUTPUT WAS SATISFACTORILY LOW. THE PATIENT WAS NEUROLOGICALLY STABLE UNTIL POSTOP DAY 5, WHEN SHE WHEN ACUTELY DECOMPENSATED FROM FULL 5/5 STRENGTH IN ALL EXTREMITIES TO 0/5 STRENGTH IN THE DISTAL UPPER EXTREMITIES AND ENTIRE LOWER EXTREMITIES. MRI DEMONSTRATED A LARGE FLUID COLLECTION IN THE SURGICAL BED CAUSING CORD COMPRESSION, AND THE PATIENT WAS EMERGENTLY RETURNED TO THE OPERATING ROOM. THE FLUID COLLECTION HAD A THIN, OFF-WHITE APPEARANCE WITH PIECES OF THE MEDTRONIC GRAFTON PLUS DBM MIXED IN WITH IT. THERE WAS NO HEMATOMA, PUS, OR CSF (MORE TYPICAL CAUSES OF POSTOPERATIVE COLLECTIONS). WE SUSPECT THAT THE PATIENT HAD AN ALLERGIC REACTION TO ONE OF THE PROCESSING AGENTS IN BONE GRAFT (E.G. SURFACTANT OR ANTIBIOTICS), A FLUID COLLECTION RESULTED FROM THE INFLAMMATORY RESPONSE.

  Patient problems: Hypersensitivity/Allergic reaction; Muscle Weakness/Atrophy; Nervous System Injury

  MAUDE report 15147850 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043048. One submission often covers many models, so check the product and lot details in each record.

• Z-0137-2027 · Aug 12, 2026 · Open, Classified
  Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a p
• Z-0088-2013 · Apr 20, 2012 · Terminated
  Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bo
• Z-0091-2013 · Apr 20, 2012 · Terminated
  Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a de
• Z-0085-2013 · Apr 20, 2012 · Terminated
  Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone mat
• Z-0086-2013 · Apr 20, 2012 · Terminated
  Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone m
• Z-0089-2013 · Apr 20, 2012 · Terminated
  Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized
• Z-0094-2013 · Apr 20, 2012 · Terminated
  Optimum Expanse S Multiple sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone ma
• Z-0087-2013 · Apr 20, 2012 · Terminated
  Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone m
• Z-0090-2013 · Apr 20, 2012 · Terminated
  Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a dem
• Z-0084-2013 · Apr 20, 2012 · Terminated
  Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matr
• Z-0093-2013 · Apr 20, 2012 · Terminated
  Optimum Expanse R Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allo
• Z-0092-2013 · Apr 20, 2012 · Terminated
  Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a de
• Z-0083-2013 · Apr 20, 2012 · Terminated
  Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone ma