MASTERGRAFT® MATRIX EXT 7610305Recalls & reported problems
Medtronic Sofamor Danek, Inc. · BLOCK 7610305 MSTRGRFT MATRIX EXT 5CC · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00643169322349), received between Oct 8, 2020 and Oct 8, 2020 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT CORPECTOMY, CERVICAL DECOMPRESSION. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE SPINAL STENOSIS; CERVICAL COMPRESSION FX. IT WAS REPORTED THAT THE MATRIX WAS IMPLANTED ON (B)(6) 2020 ,THE PLACEMENT OF THE PRODUCT WAS IN CAGE, DISC SPACE. POST OPERATION ON (B)(6) 2020 AN INFECTION WAS INDICATED PER BLOOD WORK. NEGATIVE RESULTS PER CULTURE TAKEN FOR AEROBIC AND ANAEROBIC ORGANISMS AND FUNGI. CLEAN OUT WAS PERFORMED AROUND THE CORPECTOMY DEVICE. NO FURTHER COMPLICATIONS REPORTED.
Patient problems: Unspecified Infection
MAUDE report 10647167 ↗
Other FILLER, BONE VOID, CALCIUM COMPOUND devices
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44150Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND3 recalls1 report
- 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 897005Stryker Corporation · FILLER, BONE VOID, CALCIUM COMPOUND1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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