Cortoss 2101-0005Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00808232000962), received between Mar 7, 2016 and May 2, 2017 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Apr 1, 2020Terminated

   Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism.

   Z-1900-2020 · Root cause: Storage · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2017Break; Detachment Of Device Component; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; WHEN THE GUN WAS USED TO SQUEEZE THE CEMENT OUT OF THE CARTRIDGE, THE CARTRIDGE BROKE OFF OF THE GUN AT THE BASE AND THE TIP SHOT FORWARD OFF OF THE STERILE FIELD.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6537600 ↗
• InjuryJun 30, 2016Leak/Splash; Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT; SALES REP WAS ADVISED THAT PATIENT REPORTED CHEST PAIN AFTER PRODUCT WAS USED. WENT INTO ER 3 DAYS AFTER CASE. REP REPORTED THAT CORTOSS HAD A GREAT FILL UNDER XRAY. A PULMANOGIST EXAMINED PATIENT, SUGGESTED CT THAT BE DONE. CT SHOWS THAT CEMENT LEAKED TOWARD LUNG.

  Patient problems: Chest Pain; Pain

  MAUDE report 5762365 ↗
• MalfunctionMar 7, 2016Break; Fracture; Material Integrity Problem; Break; Crack; Fracture; Split; Material Integrity Problem

  IT WAS REPORTED THAT THE IMPLANT CARTRIDGE WAS INSERTED INTO GUN AND THE CARTRIDGE SPLIT AND CRACKED WHEN THE TECH WAS ATTEMPTING TO FILL THE CEMENT CANNULA.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 5483613 ↗