MAGNIFUSE Bone GraftRecalls & reported problems across all models

We found 3 models of MAGNIFUSE Bone Graft by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Feb 27, 2018 and Jul 7, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (2 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 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

MAGNIFUSE Bone Graft 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. Jul 31, 2023Class IIOpen, Classified

   The incorrect product labeling was applied to the product indicating the wrong size of product.

   Z-2524-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported MAGNIFUSE Bone Graft problems

MAGNIFUSE Bone Graft models

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

• MAGNIFUSE® Bone Graft 7509014

  FILLER, BONE VOID, CALCIUM COMPOUND
  1 recall2 reports
• MAGNIFUSE® Bone Graft 7509145

  FILLER, BONE VOID, CALCIUM COMPOUND
  1 report
• MAGNIFUSE® Bone Graft 7509215

  FILLER, BONE VOID, CALCIUM COMPOUND
  1 report

Recent MAGNIFUSE Bone Graft adverse event reports

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

• MalfunctionJul 7, 2025Nonstandard Device; Nonstandard Device

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING BONE GRAFTS. IT WAS REPORTED THAT THE PRODUCT (14X25 MAGNIFUSE) WAS OPENED AND PLACED ON THE STERILE FIELD LIKE NORMAL. THE SCRUB TECH NOTICED THAT THE PRODUCT WAS A LOT LARGER THAN NORMAL. IT WAS MEASURED AND DETERMINED TO BE NEARLY TWICE THE SIZE OF WHAT WAS NEEDED. THEREFORE, THE PRODUCT WAS DISCARDED AND NOT USED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410554 ↗
• MalfunctionJul 7, 2025Nonstandard Device; Nonstandard Device

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING BONE GRAFTS. IT WAS REPORTED THAT THE PRODUCT (14X25 MAGNIFUSE) WAS OPENED AND PLACED ON THE STERILE FIELD LIKE NORMAL. THE SCRUB TECH NOTICED THAT THE PRODUCT WAS A LOT LARGER THAN NORMAL. IT WAS MEASURED AND DETERMINED TO BE NEARLY TWICE THE SIZE OF WHAT WAS NEEDED. THEREFORE, THE PRODUCT WAS DISCARDED AND NOT USED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410536 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH CERVICAL STENOSIS WITH MYELOPATHY FOR POSTERIOR CERVICAL FUSION SPINAL THERAPY AT C3-C5. IT WAS REPORTED THAT THE PATIENT WAS READMITTED TO HOSPITAL ON (B)(6) 2022 PRESENTING SYMPTOMS WITH INFECTION. EXPLORATION OF WOUND WAS DONE ON (B)(6) 2022 THAT SHOWED A DEEP INFECTION PUSS POCKET BELOW THE FACIAL LAYER. THE PATIENT HAS A INFECTION AND BACTEREMIA. THE PATIENT HAD FEVER OF 102 F, NAUSEA VOMITING AND ELEVATED WBC OF 17. THE PATIENT WAS TREATED WITH ANTIBIOTICS UPON ADMISSION. THE PATIENT UNDERWENT REVISION OF SURGERY FOR IRRIGATION DEBRIDEMENT REMOVAL OF GRAFT MATERIAL. THE WOUND SITE CULTURED FOR AEROBIC AND ANAEROBIC ORGANISMS AND FUNGI. THE RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE USE OF MEDTRONIC PRODUCTS IS UNKNOWN. THERE WAS NO FURTHER INFORMATION REPORTED. DATE OF ORIGINAL DISCHARGE: (B)(6)2022 DATE PATIENT DEVELOPED SYMPTOMS: (B)(6) 2022.

  Patient problems: Bacterial Infection; Fever; Vomiting

  MAUDE report 14109818 ↗
• InjuryFeb 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L1-L4 DUE TO BACK AND RADICULAR PAIN. PO ST-OP, ALTHOUGH THE PATIENT HAS DONE WELL FROM A BACK PAIN AND RADICULAR PAIN STANDPOINT, SHE HAS HAD HIVES (AN ALLERGIC REACTION) INTERMITTENTLY SINCE HER IMPLANTATION. PATIENT DOES HAVE A LATEX ALLERGY, BUT WAS NOT KNOWINGLY EXPOSED TO LATEX DURING HER SURGERY.

  Patient problems: Reaction

  MAUDE report 7298642 ↗

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