Invictus 16021Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190376284637), received between May 13, 2021 and Mar 5, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT THE TIP OF THE INSERTER SHEARED OFF. NO PIECES WERE LEFT IN THE PATIENT. THERE IS NOT REPORT OF PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842320 ↗
• MalfunctionJul 23, 2021Fracture

  THE END OF A UNIVERSAL CROSS CONNECTOR INSERTER FRACTURED WHILE TRYING TO LOOSEN A SET SCREW ON A CROSSLINK.

  Patient problems: Insufficient Information

  MAUDE report 12222177 ↗
• InjuryMay 13, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE TORQUE HANDLE DID NOT UNLOCK THE CROSS CONNECTOR SO THE INSERTER WAS USED BUT IT BROKE INSIDE THE CROSS CONNECTOR. NO INJURY TO THE PATIENT BUT A PIECE OF THE INSERTER DRIVER WAS RETAINED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11822134 ↗