MASTERGRAFT® Granules 7600115Recalls & reported problems
Medtronic Sofamor Danek, Inc. · BIOLOGIC 7600115 85 BTCP 15 HA 15CC VIAL · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00721902184987), received between May 18, 2026 and May 18, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Osseointegration Problem” (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.
Reports received per month
Most reported problems
Device problems
- Osseointegration Problem1
Patient problems
- Inadequate Osseointegration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2026Osseointegration Problem
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT HAVING POSTERIOR CERVICAL L AMINECTOMY. IT WAS REPORTED THAT IMPLANTS WERE USED DURING AN INDEX POSTERIOR SPINAL FIXATION AND FUSION FROM SKULL TO C7. AN ADDITIONAL SPINAL REVISION SURGERY WAS PERFORMED BECAUSE OF FUSION FAILURE. NO ASSESSMENT OF PRODUCT, THERAPY, OR PROCEDURE RELATEDNESS WAS MADE BY THE INVESTIGATOR, SPONSOR, OR CEC. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO ASSOCIATED MALFUNCTION REPORTED.
Patient problems: Inadequate Osseointegration
MAUDE report 25197417 ↗
Other FILLER, BONE VOID, CALCIUM COMPOUND devices
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- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42275Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls1 report
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42280Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42200Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44145Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- MAGNIFUSE® Bone Graft 7509014Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall2 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T43102Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall2 reports
- HydroSet XT 897003Stryker Corporation · FILLER, BONE VOID, CALCIUM COMPOUND1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.