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STREAMLINE™* TL SPINAL FIXATION SYSTEM 01-SETSCREWRecalls & reported problems

Pioneer Surgical Technology, Inc. · SET SCREW · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00846468006143), received between Jun 28, 2018 and Nov 25, 2020 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (4 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

Device problems

  • Migration4
  • Adverse Event Without Identified Device or Use Problem1
  • Detachment Of Device Component1

Patient problems

  • Pain2
  • No Code Available1
  • No Information1
  • No Known Impact Or Consequence To Patient1
  • Patient Problem/Medical Problem1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 25, 2020Migration; Migration

    IT WAS REPORTED TO RTI SURGICAL ON 11/3/2020 THAT DURING A PATIENT'S POST-OPERATIVE FOLLOW-UP APPOINTMENT, IT WAS CONFIRMED THAT A SET SCREW HAD LOOSENED.

    Patient problems: Pain

    MAUDE report 10900531 ↗
  • InjuryJul 14, 2020Migration; Migration

    IT WAS REPORTED TO RTI SURGICAL ON (B)(6) 2020 THAT DURING A REVISION SURGERY FOR A BROKEN (LEFT L5) PEDICLE SCREW, THE SURGEON ALSO FOUND THAT A SET SCREW (AT A DIFFERENT SITE ON THE LEFT SIDE OF THE CONSTRUCT) HAD LOOSENED POST-OPERATIVELY. THIS REPORT IS FOR THE SET SCREW. THE BROKEN PEDICLE SCREW CAN BE FOUND ON MEDWATCH REPORT NUMBER, 1833824-2020-00025.

    Patient problems: No Code Available

    MAUDE report 10271278 ↗
  • InjuryOct 30, 2019Migration; Migration

    IT WAS REPORTED THAT A PATIENT HAD TO HAVE A REVISION SURGERY ON (B)(6) 2019 DUE TO A SET SCREW BACKING OUT. THE REVISION SURGERY WAS COMPLETED.

    Patient problems: Pain

    MAUDE report 9255244 ↗
  • MalfunctionOct 10, 2018Migration; Migration

    PATIENT PRESENTED WITH POST OPERATIVE PAIN AND IT WAS NOTICED THROUGH XRAY THAT THE SCREWS HAD LOOSENED AND A ROD WAS SHIFTED OUT OF PLACE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 TO REPLACE THE RODS AND SCREWS.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 7953350 ↗
  • InjurySep 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DURING A REVISION SURGERY FOR AN UNRELATED CONCERN IT WAS IDENTIFIED THAT POSTERIOR SPINAL ROD LOCKING SET SCREWS LOOSENED. A LOCKING SET SCREW WAS REPLACED AND THE REMAINING LOCKING SET SCREWS WERE TIGHTENED.

    Patient problems: No Information

    MAUDE report 7898955 ↗
  • MalfunctionJun 28, 2018Detachment Of Device Component; Detachment Of Device Component

    IT WAS DISCOVERED AT A POST-OP APPOINTMENT THAT THE SCREW WAS BACKING OUT. THE PATIENT WAS NOT IN PAIN. THE SURGEON REVISED THE PATIENT ON (B)(6) 2018. PATIENT IS RECOVERING.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7645105 ↗

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Sources and updates

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