GRAFTON® DBM T44115INTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169134324), received between Mar 14, 2019 and Apr 1, 2019 — classified as 4 injuries.

15 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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¿GRAM NEGATIVE BACTERIA¿ WAS FOUND IN THE RESULT ON THE WOUND SITE. PATIENT NEVER HAD FEVER AND ALSO PATIENT¿S IMMUNE WAS NOT COMPROMISED AND HE WAS NOT UNDERGOING CHEMOTHERAPY. THE PATIENT RECOVERED FEW DAYS LATER AND DISCHARGED FROM HOSPITAL.

  Patient problems: Reaction; Unspecified Infection

  MAUDE report 8468481 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCOLIOSIS CORRECTION SURGERY FROM T6 TO S1. POST-OP, ONE MONTH LATER, THE IMPLANTATION OF THE TISSUES, THE PATIENT SUFFERED DUE TO INFECTION IN WOUND. PATIENT IMMUNE WAS NOT COMPROMISED AND SHE WAS NOT UNDERGOING CHEMOTHERAPY. PATIENT WENT THROUGH 24 HOUR PROPHYLAXIS PROTOCOL AFTER THE INITIAL SURGERY. THE SYMPTOMS APPEARED 10 DAYS AFTER THE INITIAL SURGERY BECAUSE 10 DAYS LATER WHEN THEY WERE GOING TO REMOVE THE STITCHES, THE PATIENT INDICATED THAT THE WOUND WAS OPEN. PATIENT SUFFERED DUE TO FEVER AS WELL APPROX 3 WEEKS AFTER THE INITIAL SURGERY. PATIENT UNDERWENT REVISION SURGERY, WHERE THE IMPLANTS WERE EXTRACTED AND A SAMPLE HAVE BEEN SENT TO THE LABORATORY TO DETERMINE IF THE INFECTION WAS CAUSED BY THE IMPLANTS. AS PER THE LATEST UPDATE, PATIENT WAS STILL IN THE HOSPITAL (ICU). DOCTORS PERFORMED ANOTHER WASHING OF THE WOUND SITE BECAUSE THE WOUND WAS GETTING INFECTED. AT THE WOUND SITE, DOCTORS FOUND A BACTERIUM CALLED "LARGE NEGATIVE GERM¿. ALSO IN THE BLOOD CULTURE THEY FOUND A STAPHYLOCOCCUS. THEY DID AN ECHOCARDIOGRAM AND IT CAME OUT NEGATIVE. THE DOCTOR STATES THAT IT IS NOT CERTAIN THAT THE GRAFT IS THE INITIAL CAUSE OF THE EVE

  Patient problems: Post Operative Wound Infection

  MAUDE report 8419792 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCOLIOSIS CORRECTION SURGERY FROM T6 TO S1. POST-OP, ONE MONTH LATER THE IMPLANTATION OF THE TISSUES, THE PATIENT SUFFERED DUE TO INFECTION IN WOUND. PATIENT IMMUNE WAS NOT COMPROMISED AND SHE WAS NOT UNDERGOING CHEMOTHERAPY. PATIENT WENT THROUGH 24 HOUR PROPHYLAXIS PROTOCOL AFTER THE INITIAL SURGERY. THE SYMPTOMS APPEARED 10 DAYS AFTER THE INITIAL SURGERY BECAUSE 10 DAYS LATER WHEN THEY WERE GOING TO REMOVE THE STITCHES, THE PATIENT INDICATED THAT THE WOUND WAS OPEN. PATIENT SUFFERED DUE TO FEVER AS WELL APPROX 3 WEEKS AFTER THE INITIAL SURGERY. PATIENT UNDERWENT REVISION SURGERY, WHERE THE IMPLANTS WERE EXTRACTED AND A SAMPLE HAVE BEEN SENT TO THE LABORATORY TO DETERMINE IF THE INFECTION WAS CAUSED BY THE IMPLANTS. AS PER THE LATEST UPDATE, PATIENT WAS STILL IN THE HOSPITAL (ICU). DOCTORS PERFORMED ANOTHER WASHING OF THE WOUND SITE BECAUSE THE WOUND WAS GETTING INFECTED. AT THE WOUND SITE, DOCTORS FOUND A BACTERIUM CALLED "LARGE NEGATIVE GERM¿. ALSO IN THE BLOOD CULTURE THEY FOUND A STAPHYLOCOCCUS. THEY DID AN ECHOCARDIOGRAM AND IT CAME OUT NEGATIVE. THE DOCTOR STATES THAT IT IS NOT CERTAIN THAT THE GRAFT IS THE INITIAL CAUSE OF THE EVEN

  Patient problems: Post Operative Wound Infection

  MAUDE report 8419790 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCOLIOSIS CORRECTION SURGERY FROM T6 TO S1. POST-OP, ONE MONTH LATER THE IMPLANTATION OF THE TISSUES, THE PATIENT SUFFERED DUE TO INFECTION IN WOUND. PATIENT IMMUNE WAS NOT COMPROMISED AND SHE WAS NOT UNDERGOING CHEMOTHERAPY. PATIENT WENT THROUGH 24 HOUR PROPHYLAXIS PROTOCOL AFTER THE INITIAL SURGERY. THE SYMPTOMS APPEARED 10 DAYS AFTER THE INITIAL SURGERY BECAUSE 10 DAYS LATER WHEN THEY WERE GOING TO REMOVE THE STITCHES, THE PATIENT INDICATED THAT THE WOUND WAS OPEN. PATIENT SUFFERED DUE TO FEVER AS WELL APPROX 3 WEEKS AFTER THE INITIAL SURGERY. PATIENT UNDERWENT REVISION SURGERY, WHERE THE IMPLANTS WERE EXTRACTED AND A SAMPLE HAVE BEEN SENT TO THE LABORATORY TO DETERMINE IF THE INFECTION WAS CAUSED BY THE IMPLANTS. AS PER THE LATEST UPDATE, PATIENT WAS STILL IN THE HOSPITAL (ICU). DOCTORS PERFORMED ANOTHER WASHING OF THE WOUND SITE BECAUSE THE WOUND WAS GETTING INFECTED. AT THE WOUND SITE, DOCTORS FOUND A BACTERIUM CALLED "LARGE NEGATIVE GERM¿. ALSO IN THE BLOOD CULTURE THEY FOUND A STAPHYLOCO CCUS. THEY DID AN ECHOCARDIOGRAM AND IT CAME OUT NEGATIVE. THE DOCTOR STATES THAT IT IS NOT CERTAIN THAT THE GRAFT IS THE INITIAL CAUSE OF THE EVE

  Patient problems: Post Operative Wound Infection

  MAUDE report 8419789 ↗

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-0166-2024 · Sep 26, 2023 · Open, Classified
  Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
• Z-1329-2023 · Feb 8, 2023 · Open, Classified
  Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; d) DBM
• 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-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-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-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
• 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-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-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-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-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-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-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-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