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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

All FILLER, BONE VOID, CALCIUM COMPOUND devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.