GRAFTON DBMRecalls & reported problems across all models

We found 11 models of GRAFTON DBM by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Feb 5, 2018 and Mar 30, 2021 — classified as 9 injuries.

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

3 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

GRAFTON DBM recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-1328-2023 · Root cause: Process control · Recall details · FDA record ↗

2. 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-1326-2023 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

3. 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 · names 5 of these models · Recall details · FDA record ↗

Most reported GRAFTON DBM problems

GRAFTON DBM models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GRAFTON® DBM T43110INT

  BONE GRAFTING MATERIAL, HUMAN SOURCE
  1 recall2 reports
• GRAFTON® DBM T44150INT

  Filler, bone void, osteoinduction (w/o human growth factor)
  1 recall1 report
• GRAFTON™ DBM T42275INT

  Filler, bone void, osteoinduction (w/o human growth factor)
  1 recall0 reports
• GRAFTON® DBM T43101INT

  BONE GRAFTING MATERIAL, HUMAN SOURCE
  1 recall0 reports
• GRAFTON® DBM T43102INT

  BONE GRAFTING MATERIAL, HUMAN SOURCE
  1 recall0 reports
• GRAFTON® DBM T43103INT

  BONE GRAFTING MATERIAL, HUMAN SOURCE
  1 recall0 reports
• GRAFTON® DBM T43105INT

  BONE GRAFTING MATERIAL, HUMAN SOURCE
  1 recall0 reports
• GRAFTON® DBM T44135INT

  Filler, bone void, osteoinduction (w/o human growth factor)
  1 recall0 reports
• GRAFTON® DBM T44115INT

  Filler, bone void, osteoinduction (w/o human growth factor)
  4 reports
• GRAFTON® DBM T43110INT

  BONE GRAFTING MATERIAL, HUMAN SOURCE
  1 report
• GRAFTON® DBM T42308INT

  BONE GRAFTING MATERIAL, HUMAN SOURCE
  1 report

Recent GRAFTON DBM adverse event reports

The 9 most recent reports across all models, 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 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH MAXILLARY CYST; AND UNDERWENT RESECTION AND CURETTAGE OF BENIGN UPPER JAW INJURY AND MAXILLARY BONE BIOPSY. THE GRAFT WAS PLACED ON THE UPPER JAW. ALLEGEDLY, ON AN UNKNOWN DATE, POST-OP, THE PATIENT HAD AN INFECTION AT THE TREATED SITE. THE SYMPTOMS OF THE INFECTION INCLUDED FEVER, INFLAMMATION OF THE AREA AND EXPULSION OF LIQUID THROUGH THE WOUND IN THE ORAL MUCOSA. ANTIBIOTIC TREATMENT WAS CARRIED OUT DUE TO THIS EVENT. ACCORDING TO THE SURGEON, THE INFECTION WAS CAUSED BY POOR ORAL HYGIENE OF THE PATIENT. HENCE, IT WAS RECOMMENDED TO WASH THE AREA WITH ORAL ANTISEPTIC TO DECREASE SYMPTOMS AND SIGNS OF INFECTION.

  Patient problems: Fever; Inflammation; Unspecified Infection

  MAUDE report 10196836 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryFeb 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT DENTAL SURGERY IN WHICH THE BONE GRAFT WAS USED. IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT COMPLAINED OF HAVING HERPES 1 AND 2 VIRUS. THE SURGEON IS UNSURE IF THE CAUSE OF THE DISEASE IS THE GRAFT.

  Patient problems: Herpes

  MAUDE report 7240885 ↗

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