STREAMLINE™* TL SPINAL FIXATION SYSTEM 01-PA-65-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00846468005658), received between May 31, 2018 and Mar 7, 2024 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2024Break; Off-Label Use; Improper or Incorrect Procedure or Method; Break; Off-Label Use; Improper or Incorrect Procedure or Method

  OUR OEM DISTRIBUTION REP STATED "XTANT MEDICAL HAS RECEIVED A PRODUCT COMPLAINT FROM THE STREAMLINE TL SPINAL FIXATION SYSTEM, IN WHICH IT WAS REPORTED THAT TWO PEDICLE SCREW IMPLANTS (01-PA-65-45, LOTS: 381268 AND 380862) WERE IDENTIFIED AS BROKEN, WHICH REQUIRED A REVISION PROCEDURE. XTANT MEDICAL HAS INITIATED COMPLAINT: (B)(4) ON THE ISSUE. BELOW IS RELEVANT INFORMATION PROVIDED BY THE COMPLAINT SOURCE, PLEASE LET ME KNOW IF YOU HAVE ANY QUESTIONS OR CONCERNS, APPRECIATE THE ASSISTANCE. COMMENTARY PROVIDED: PATIENT WAS IMPLANTED ON (B)(6) 2023, ON (B)(6) 2023, PATIENT CAME IN AND REPORTS 95% IMPROVED AND WAS PLEASED WITH SURGERY RESULT. ON APPROXIMATELY ON (B)(6) 2024, A STRANGE SQUEAKING NOISE BEGAN. ON (B)(6) 2024, CT SCAN SHOWS VERTICAL NONDISPLACED FRACTURES THROUGH THE BILATERAL S1 PEDICLE SCREWS AT BOTH OSSEOUS ENTRY POINTS. INDEX PROCEDURE PERFORMED ON (B)(6) 2023. REVISION PROCEDURE PERFORMED ON (B)(6) 2024".

  Patient problems: Failure of Implant

  MAUDE report 18860013 ↗
• InjuryMar 7, 2024Break; Off-Label Use; Improper or Incorrect Procedure or Method; Break; Off-Label Use; Improper or Incorrect Procedure or Method

  OUR OEM DISTRIBUTION REP STATED "XTANT MEDICAL HAS RECEIVED A PRODUCT COMPLAINT FROM THE STREAMLINE TL SPINAL FIXATION SYSTEM, IN WHICH IT WAS REPORTED THAT TWO PEDICLE SCREW IMPLANTS (01-PA-65-45, LOTS 381268 AND 380862) WERE IDENTIFIED AS BROKEN, WHICH REQUIRED A REVISION PROCEDURE. XTANT MEDICAL HAS INITIATED COMPLAINT (B)(4) ON THE ISSUE. ATTACHED IS THE IMAGING PROVIDED BY THE COMPLAINT SOURCE. BELOW IS RELEVANT INFORMATION PROVIDED BY THE COMPLAINT SOURCE, PLEASE LET ME KNOW IF YOU HAVE ANY QUESTIONS OR CONCERNS, APPRECIATE THE ASSISTANCE. COMMENTARY PROVIDED: PATIENT WAS IMPLANTED (B)(6) 2023, ON (B)(6) 2023 PATIENT CAME IN AND REPORTS 95% IMPROVED AND WAS PLEASED WITH SURGERY RESULT. ON APPROXIMATELY (B)(6) 2024 A STRANGE SQUEAKING NOISE BEGAN. ON (B)(6) 2024 CT SCAN SHOWS VERTICAL NONDISPLACED FRACTURES THROUGH THE BILATERAL S1 PEDICLE SCREWS AT BOTH OSSEOUS ENTRY POINTS. INDEX PROCEDURE PERFORMED (B)(6) 2023, REVISION PROCEDURE PERFORMED (B)(6) 2024".

  Patient problems: Failure of Implant

  MAUDE report 18859552 ↗
• InjuryMay 31, 2018Disassembly; Disassembly

  A POSTERIOR SPINAL FUSION SURGERY WAS PERFORMED ON THE PATIENT ON (B)(6) 2018. PATIENT STARTED TO HAVE PAIN A FEW WEEKS AFTER THIS INITIAL SURGERY. A CT SCAN WAS COMPLETED FOR THIS PATIENT AND THE SCAN SHOWED THAT THE PEDICLE SCREW HEAD DISASSEMBLED. THE PATIENT WAS REVISED ON (B)(6) 2018 AND THE DISASSEMBLED SCREW WAS REMOVED AND REPLACED.

  Patient problems: Intraoperative Pain

  MAUDE report 7557894 ↗