Skip to content

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

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: 1 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: 0 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

  • 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

All FILLER, BONE VOID, CALCIUM COMPOUND devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page