Streamline® TL Spinal Fixation System 02-FINALDRIVERRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00846468006198), received between Oct 15, 2025 and Feb 6, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Break

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 01/07/2026. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER WAS BROKEN DURING A HARDWARE REMOVAL PROCEDURE. THE FRACTURED TIP WAS RECOVERED, AND AN ALTERNATE AVAILABLE INSTRUMENT WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. A RETURN AUTHORIZATION WAS ISSUED FOR THE RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 01/23/2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283899 ↗
• MalfunctionDec 31, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  A FOLLOW-UP REPORT TO 3005031160-2025-00047 SUBMITTED ON 12/31/2025 IS BEING SUBMITTED AS ADDITIONAL INFORMATION IS AVAILABLE AND THE MANUFACTURER HAS COMPLETED INVESTIGATION ACTIVITITES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936508 ↗
• MalfunctionDec 31, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  A FOLLOW-UP REPORT TO 3005031160-2025-00045 SUBMITTED ON (B)(6) 2025 IS BEING SUBMITTED AS ADDITIONAL INFORMATION IS AVAILABLE AND THE MANUFACTURER HAS COMPLETED INVESTIGATION ACTIVITITES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936490 ↗
• MalfunctionOct 15, 2025Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2025. IT WAS REPORTED THAT THE TIP OF A FINAL DRIVER WAS DAMAGED WHEN REMOVING SCREWS DURING A LUMBAR FUSION PROCEDURE PERFORMED ON (B)(6) 2025. AN ALTERNATIVE INSTRUMENT WAS AVAILABLE TO SUCCESSFULLY COMPLETE THE SURGERY. THERE WAS NO DELAY IN SURGERY AND NO KNOWN PATIENT COMPLICATIONS. A RETURN AUTHORIZATION WAS ISSUED FOR THE RETURN OF THE COMPLAINT DRIVER, WHICH WAS RECEIVED BY THE MANUFACTURER ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23295276 ↗