nanOss ABGS 90-100-10Recalls & reported problems
Pioneer Surgical Technology, Inc. · Bone Void Filler 10cc · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846468049461), received between Jul 23, 2024 and Jul 23, 2024 — classified as 1 death.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Cardiac Arrest1
- Embolism/Embolus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJul 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL FOUR (4) LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE AT C3 TO C7 USING TWO ANTERIOR INTERBODIES AND AN ANTERIOR PLATE SYSTEM AND A POSTERIOR CERVICAL FIXATION FROM C3 TO C7 USING A COMPETITOR POSTERIOR INTERBODY AND SCREW SYSTEM. DURING THE PROCEDURE, AFTER THE ANTERIOR PORTION OF THE PROCEDURE WAS COMPLETED AND DURING CLOSURE OF THE ANTERIOR SITE, IT WAS NOTED THAT THE PATIENT CODED AND WAS ABLE TO BE REVIVED. SUBSEQUENTLY, WHILE IN THE PROCESS OF FLIPPING THE PATIENT FROM ANTERIOR TO POSTERIOR, APPROXIMATELY 10 MINUTES AFTER CLOSURE OF THE ANTERIOR SITE, THE PATIENT SUFFERED A CARDIAC ARREST AND WAS UNABLE TO BE REVIVED. IT WAS BELIEVED THAT THE PATIENT MAY HAVE EXPERIENCED A PULMONARY EMBOLUS DURING THE FLIP MANEUVER. NO COMPLICATIONS WERE NOTED DURING THE ANTERIOR PORTION OF THE PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Cardiac Arrest; Embolism/Embolus
MAUDE report 19809795 ↗
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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