MASTERGRAFT® Granules 7600105Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00721902168734), received between Sep 29, 2017 and Dec 17, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRE-OPERATIVE DIAGNOSIS: LUMBAR CANAL STENOSIS. PROCEDURE: MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). IT WAS REPORTED THAT POST-OP, PATIENT FELT PAIN WHEN PRESSING THE LUMBER REGION AROUND THE SURGERY. INFLAMMATORY RESPONSE WAS FOUND BY BLOOD TEST. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT.

  Patient problems: Inflammation; Pain

  MAUDE report 8170963 ↗
• InjurySep 29, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT LEVELS L4-5. POST OP,ON (B)(6) 2017, POST OP, RADIOLOGY REPORT POINTED OUT AN ARTIFICIAL BONE (EQUIVALENT TO BONE) IS FLOWING IN THE SPINAL CANAL (UNTIL L2-3). THE DEVICE WAS USED IN A CAGE AND THE INTERVERTEBRAL DISC WITH AUTOLOGOUS BONE BY MEANS OF PLF BECAUSE THE AMOUNT OF AUTOLOGOUS BONE WAS NOT ENOUGH. THERE IS A POSSIBILITY THAT THE ARTIFICIAL BONE USED FOR THE INTERVERTEBRAL DISC IS MELTED. THE PATIENT COMPLAINED OF PAIN IN THE FEMUR IN THE 4TH DAY AFTER THE SURGERY. NEUROLOGICAL SYMPTOM HAS NOT OCCURRED.

  Patient problems: Pain

  MAUDE report 6903279 ↗