GRAFTON® DBM T43110INT (UDI 00643169965003)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169965003), received between Feb 11, 2019 and Sep 26, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

13 other recalls cover devices cleared under the same FDA submission (K051188); 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 16, 2026.

Recalls naming this device

1. Feb 8, 2023Open, 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-1323-2023 · 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.

• InjurySep 26, 2019Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LAMINECTOMY AND POSTERIOR ARTHRODESIS AT L4-L5. DURING THE SURGERY, THE SURGEON PLACED 10 CC PUTTY INTO THE PATIENT. NO CAGE WAS USED; THE SURGEON ONLY PUT SCREWS AND ROD MANUFACTURED BY MEDI IMPLANTS. NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. APPROXIMATELY A WEEK AFTER THE SURGERY, REPORTEDLY, THE PATIENT HAD A RELAPSE AND HAD LOW LEVELS OF SATURATION AMONG OTHER SYMPTOMS. THE PATIENT REPORTED EXPERIENCING A RARE FEELING. THE SURGEON PLANNED A REVISION SURGERY DUE TO THIS EVENT. ON (B)(6) 2019, THE REVISION SURGERY WAS PERFORMED. WHEN THE WOUND WAS OPENED, IT WAS OBSERVED THAT THE GRAFT HAD A BLACK-GRAY COLOR AND HAD AN ABNORMAL APPEARANCE. THE SURGEON THEN COMMENTED THAT THE GRAFT WAS BAD AND THAT THE PATIENT'S BODY COULD HAVE REJECTED THE GRAFT. HENCE, EVERYTHING IMPLANTED DURING THE INITIAL SURGERY WAS COMPLETELY EXPLANTED. THE ITEMS THAT WERE EXPLANTED INCLUDED THE REPORTED GRAFT, THE SCREWS AND THE ROD. THE PATIENT HAD TO BE HOSPITALIZED DUE TO THIS EVENT. THERE WAS NO POST-OP INFECTION, OR IMMUNOLOGICAL OR INFLAMMATORY RESPONSE REPORTED. PATIENT ISSUE HAS BEEN REPORTED TO BE RESOLVED.

  Patient problems: Discomfort

  MAUDE report 9122085 ↗
• InjuryFeb 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DATE REQUEST FOR TISSUE: (B)(6) 2018 THE PATIENT FROM THE BEGINNING CAME WITH HEALTH PROBLEMS DIFFERENT FROM HER COLUMN. ACCORDING TO THE DOCTOR'S CONCEPT, THE BONE MATRIX HAD NOTHING TO DO WITH THE INFECTION. SURGEON SAYS THAT IT IS THE ACCUMULATION OF DIFFERENT EVENTS THAT LED TO THE STATE OF INFECTION OF THE PATIENT. SURGEON TELLS US THAT AFTER IDENTIFYING THE INFECTION, ALL OF THE MOS IS REMOVED AND TREATED WITH ANTIBIOTICS, BUT SOON AFTER SURGEON DID NOT SPECIFY WHEN, A BONE SUBSTITUTE WAS IMPLANTED WITH AN ANTIBIOTIC WHICH APPARENTLY DID NOT WORK AND THE INFECTION INCREASED. SURGICAL PROCEDURE: CHANNEL LUMBAR NARROW + GRAFT BONE IN SPINAL COLUMN VIA BACK DESCRIPTION OF WOUND SITE: PATIENT IS SUBMITTED FOR INFECTION OF THE LUMBAR ARRODESIS POSTERIOR L4, L5 AND L5 S1 OPERATION SITE, PLUS LAMINECTOMY WITH SCREENING AND EXPLORATION OF SIDE RAQUIDEO CHANNEL FOR BILATERAL FORAMINOTOMIAS AND LUMBAR DISC EXCISION PLUS MATRIX APPLICATION OSEA IN ANTERIOR AND POSTERIOR LUMBAR COLUMN MADE IN THE INSTITUTION, PRESENTS ISO DISCITE DISCITES, ANTIBIOTIC HANDLING IS INSTANTED, HAS REQUIRED REPLACEMENT OF VAC SYSTEM BY PART OF COLUMN SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 8325390 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051188. One submission often covers many models, so check the product and lot details in each record.

• Z-0977-2014 · Jan 6, 2014 · Terminated
  Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - f
• 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-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-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-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-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-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-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-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-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-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-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