Streamline™* MIS Spinal Fixation System 05-PA-65-50Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846468052386), received between Jul 14, 2020 and Dec 9, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Code Available1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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) 2016. REVISION SURGERY TO REPLACE THE SCREW WAS PERFORMED ON (B)(6) 2020. THE SCREW IS NOT AVAILABLE FOR EVALUATION.
Patient problems: Pain
MAUDE report 10977758 ↗InjuryJul 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO RTI SURGICAL ON (B)(6) 2020 THAT A STREAMLINE MIS PEDICLE SCREW TULIP DISASSOCIATED POST-OPERATIVELY. THE INDEX SURGERY (L1-S1) WAS PERFORMED ON (B)(6) 2020. DURING POST-OP FOLLOW-UP, X-RAYS CONFIRMED THAT THE PEDICLE SCREW AT THE LEFT L5 HAD DISASSOCIATED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO REPLACE THE SCREW. DURING THE REVISION SURGERY, IT WAS ALSO DETERMINED THAT A SET SCREW (AT A DIFFERENT SITE ON THE LEFT SIDE OF THE CONSTRUCT) HAD LOOSENED POST-OPERATIVELY. THE LOOSENED SCREW WAS REPLACED WITH A NEW ONE. THE SET SCREW IS ON MEDWATCH REPORT NUMBER, 1833824-2020-00026.
Patient problems: No Code Available
MAUDE report 10271222 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
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- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 reports
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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