Streamline® MIS Spinal Fixation System 04-CANNTAP-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846468050245), received between Nov 20, 2018 and Aug 22, 2024 — classified as 2 malfunctions.

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

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MINIMALLY INVASIVE SPINE SURGERY WITH A MODIFIED TRANSFORAMINAL LUMBAR INTERBODY FUSION PLACEMENT USING A MIS APPROACH. DURING THE PROCEDURE, WHILE BEING USED OVER A GUIDEWIRE, THE DISTAL TIP OF THE CANNULATED TAP FRACTURED OFF THE TIP AND WAS SUCCESSFULLY RECOVERED WITHOUT INCIDENT. AN ALTERNATE INSTRUMENT WAS USED TO FINISH THE PROCEDURE THAT RESULTED IN A THIRTY (30) MINUTE DELAY. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041542 ↗
• MalfunctionNov 20, 2018Break; Break

  DURING SURGERY THE SURGEON WAS BACKING OUT THE CANNTAP AND HE HEARD IT BREAK. IT TOOK AN HOUR FOR THE SURGEON TO REMOVE THE TIP FROM THE PATIENT. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8088720 ↗