Streamline® MIS Spinal Fixation System 04-JAMTROCAR-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846468049348), received between Jun 8, 2018 and Jun 8, 2018 — classified as 1 malfunction.

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2018Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED TO RTI SURGICAL THAT A SURGEON BROKE THE HANDLES OFF OF TWO TROCAR INSTRUMENTS DURING A SURGERY. BECAUSE THE PATIENT HAD HARD BONE THE SURGEON HAD TO DRILL TO ACCESS THE BONE.THERE WAS A 60-MINUTE DELAY OF SURGERY WITH NO PATIENT EFFECT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7583440 ↗