Streamline™* MIS Spinal Fixation System 05-PA-65-40Recalls & 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 00846468052362), received between Jun 22, 2017 and Dec 5, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Disassembly1
Patient problems
- Intraoperative Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
RTI ATTEMPTED TO SUBMIT THIS INITIAL REPORT TO THE FDA ON (B)(6) 2018. IT HAS RECENTLY COME TO OUR ATTENTION THAT THIS REPORT DID NOT GO THROUGH THE ELECTRONIC SUBMISSION COMPLETELY AND DOES NOT SHOW UP ON THE MAUDE DATABASE. FOR THIS REASON, RTI SURGICAL IS RESUBMITTING THIS INITIAL REPORT. THE INITIAL COMPLAINT "IT WAS REPORTED BY A REP THAT A SCREW HAD DISASSOCIATED POST-OPERATIVELY AND AS A RESULT A REVISION SURGERY WAS DONE."
Patient problems: Intraoperative Pain
MAUDE report 9415603 ↗InjuryJun 22, 2017Disassembly; Disassembly
THE PATIENT HAD A POSTERIOR SPINAL ROD FIXATION SURGERY ON (B)(6) 2017. APPROXIMATELY 2 WEEKS POST OP, THE PATIENT CAME IN FOR A FOLLOW UP VISIT AND IT WAS FOUND THAT ONE OF THE PEDICLE SCREWS HAD DISASSOCIATED. THE PATIENT WAS REVISED AND THE SCREW WAS REPLACED.
Patient problems: Intraoperative Pain
MAUDE report 6661057 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
- CD HORIZON® Spinal System 7540020Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation257 reports
- MANTIS Redux 48289999Stryker Corporation · Orthosis, spondylolisthesis spinal fixation76 reports
- 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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