GRAFTON® DBM T43110INT (UDI 00643169134287)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169134287), received between Mar 30, 2021 and Mar 30, 2021 — classified as 1 injury.

14 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 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.

• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INFORMATION WAS RECEIVED FROM REGULATORY AGENCIES REGARDING A PATIENT WITH FRACTURE FOR OLIF SPINAL FUSION THERAPY AT L2-L4. IT WAS REPORTED THAT ON (B)(6) 2016, A YOUNG WOMAN SUSTAINED A SEVERE LWK 3 FRACTURE WITH HIGH-GRADE INJURY OF THE SPINAL CANAL AS WELL AS LESION OF THE NERVE SAC (DURAL SAC) AND THE ROOT KNEE L3 ON THE LEFT WITH INCOMPLETE PARAPLEGIA. SHE WAS SUBSEQUENTLY REPATRIATED IN AN EMERGENCY AND HOSPITALISED AT THE UNIVERSITY HOSPITAL (B)(6), WHERE A DECOMPRESSION AND LAMINECTOMY OF L2 TO 3 AS WELL AS A STRAIGHTENING OF THE VERTEBRAL BODY AND SUTURING OF THE TORN DURA WERE PERFORMED IN AN EMERGENCY. THE VERTEBRAL BODY WAS SO DESTROYED THAT IT HAD TO BE REPLACED. THE PATIENT WAS IMPLANTED WITH A T2-ALTITUDE CENTERPIECE 19X28MM 19C (PROCEDURE: OLIF LEFT L2-L4) AND A 2X4° TOP AND BOTTOM ENDPLATE ON (B)(6) 2016 AT THE UNIVERSITY HOSPITAL (B)(6). IN ADDITION, DEMINERALISED BONE MATRIX WITH AUTOLOGOUS CANCELLOUS BONE WAS CREATED. THE BONE MATRIX IS A COMMERCIAL DEMINERALISED BONE MATRIX. AUTOLOGOUS BONE WAS ALSO HARVESTED FROM THE PATIENT AND REIMPLANTED. SINCE THE IMPLANTATION, THE PATIENT HAS REPEATEDLY EXPERIENCED VARIOUS HEALTH PROBLEMS. IN THE MEANTIME, A NICKEL A

  Patient problems: Bone Fracture(s); Nerve Damage; Paraplegia; Spinal Column Injury; Spinal Cord Injury

  MAUDE report 11587620 ↗

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-0138-2027 · 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 par
• 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-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-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-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-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-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-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-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-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