MAGNIFUSE® Bone Graft 7509145Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994986542), received between Apr 14, 2022 and Apr 14, 2022 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K082615); 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.

• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082615. One submission often covers many models, so check the product and lot details in each record.

• Z-2524-2023 · Jul 31, 2023 · Open, Classified
  Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.