NA 0306110000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540434289), received between Jul 3, 2018 and Jul 29, 2025 — 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.

• MalfunctionJul 29, 2025Fracture; Fracture

  NO CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647023 ↗
• InjuryMar 28, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT HAD AN EPIDURAL HEMATOMA THE DAY AFTER UNDERGOING A MILD PROCEDURE USING THE STRYKER DEVICE. THE DOCTOR STATED THE PROCEDURE WENT SMOOTHLY AND THE PATIENT LEFT WITHOUT ANY REPORTED ISSUES. THE PATIENT INFORMED THE DOCTOR THAT THEY WEN TO THE ER THE FOLLOWING DAY WITH SYMPTOMS UNKNOWN AND THAT IS WHEN THE EPIDURAL HEMATOMA WAS FOUND. THE PATIENT WILL BE TAKEN FOR A DECOMPRESSION SURGERY.

  Patient problems: Hematoma

  MAUDE report 21721877 ↗
• MalfunctionJul 3, 2018Break; Break

  IT WAS REPORTED THAT THE CANNULA BROKE OFF IN THE PATIENT. NO ATTEMPTS WERE MADE TO REMOVE THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADDITIONAL ADVERSE CONSEQUENCES REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7657980 ↗