CortossRecalls & reported problems across all models

We found 3 models of Cortoss by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Mar 7, 2016 and Aug 9, 2018 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Cortoss recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · FDA record ↗

Most reported Cortoss problems

Cortoss models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Cortoss 2101-0005

  CEMENT, BONE, VERTEBROPLASTY
  1 recall3 reports
• Cortoss 2101-0010

  CEMENT, BONE, VERTEBROPLASTY
  1 recall1 report
• Cortoss 2110-0039

  CEMENT, BONE, VERTEBROPLASTY
  4 reports

Recent Cortoss adverse event reports

The 8 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2018Leak/Splash; Migration or Expulsion of Device; Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A PATIENT¿S BONE BECAUSE IT WAS BROKEN, CORTOSS WAS BEING INJECTED AT THE L5 LEVEL WHEN IT MIGRATED INTO THE PATIENT¿S HEART. THE LEAKAGE WAS NOTICED WITH FLUOROSCOPY. THE PROCEDURE ENDED EARLY AND THE PATIENT WAS PUT ON SHORT TERM ANTI-COAGULANTS. THE REPRESENTATIVE NOTED THE MATERIAL HAD MIGRATED INTO A VEIN WHEN THE DOCTOR WAS TRYING TO PUT A NEEDLE IN THE OTHER SIDE, AND THE BONE HE WAS HAMMERING THE NEEDLE ON WAS SO HARD IT CAUSED THE MATERIAL TO JIGGLE LOOSE. IT WAS NOTED THERE WERE NO ISSUE WITH THE CORTOSS MATERIAL DURING THE PROCEDURE.

  Patient problems: Embolism; Foreign Body In Patient

  MAUDE report 7770534 ↗
• MalfunctionFeb 6, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE CONNECTOR WAS BROKEN WHILE TIGHTENING THE INTERCONNECTION DURING ROD PLACEMENT STAGE. A SPARE IMPLANT WAS USED TO COMPLETE THE SURGERY. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7244231 ↗
• MalfunctionNov 21, 2017Break; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT; LOCKING SCREW BROKE IN PLATE. UPDATE 10/31/2017: EVENT OCCURED DURING SURGERY.

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

  MAUDE report 7049722 ↗
• MalfunctionMay 17, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; SALES REP STATES THE DELIVERY GUN TRIGGER BROKE DURING INJECTION.

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

  MAUDE report 6572679 ↗
• 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 ↗
• MalfunctionSep 14, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT THE DELIVERY GUN BROKE. THE PLUGGER BROKE DURING THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5951241 ↗
• 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 ↗

Other Stryker Corporation products

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