MAGNIFUSE® Bone Graft 7509215Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994986559), received between Feb 27, 2018 and Feb 27, 2018 — 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. How this data works · Data updated Oct 13, 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.

• 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 ↗

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.