Streamline® MIS Spinal Fixation System 05-SCREW-INS-THRDRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846468050672), received between Mar 15, 2018 and Apr 17, 2018 — 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.

• MalfunctionApr 17, 2018Break; Break

  DURING THE FINAL LOCKING OF THE SET SCREW ON A POSTERIOR SPINAL FUSION SURGERY THE TIP OF THE SCREW DRIVER BROKE OFF INTO THE HEAD OF THE SET SCREW AND WAS LEFT IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7437765 ↗
• MalfunctionMar 15, 2018Break; Break

  DURING A SPINAL SURGERY, THE HEX TIP PORTIONS OF TWO SCREW DRIVERS BROKE OFF IN THE SCREW HEADS AND WERE NOT ABLE TO BE REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY AND WITH NO INJURY TO THE PATIENT. SINCE THE BROKEN TIPS WERE CONTAINED WITHIN THE SPINAL CONSTRUCT AND BENEATH THE LOCKED SPINAL ROD, THE SURGEON BELIEVES THAT THIS WILL HAVE NO NEGATIVE RESULTS ON THE CONSTRUCT OR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7340951 ↗