Streamline™* MIS Spinal Fixation System 05-PA-75-55Recalls & reported problems
Pioneer Surgical Technology, Inc. · CANNULATED SCREW, POLYAXIAL · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846468052546), received between Dec 9, 2020 and Dec 9, 2020 — classified as 1 injury, 1 malfunction.
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
Device problems
- Break2
- Material Fragmentation1
Patient problems
- Device Embedded In Tissue or Plaque1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2020Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED TO RTI SURGICAL ON (B)(6) 2020 THAT DURING A SURGERY, THE THREADS OF THE SCREW BROKE OFF IN THE PATIENT AND COULD NOT BE RETRIEVED. DUE TO THE BROKEN THREADS, THE SURGEON SKIPPED THAT LEVEL IN SURGERY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10977770 ↗InjuryDec 9, 2020Break; Break
IT WAS REPORTED TO RTI SURGICAL ON (B)(6) 2020 THAT A STREAMLINE MIS PEDICLE SCREW DISASSOCIATED POST-OPERATIVELY. INDEX SURGERY WAS PERFORMED ON (B)(6) 2019. REVISION SURGERY TO REPLACE THE SCREW WAS PERFORMED ON (B)(6) 2020. THE SCREW IS NOT AVAILABLE FOR EVALUATION.
Patient problems: Pain
MAUDE report 10977765 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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