Streamline™* MIS Spinal Fixation System 05-PA-75-40Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00846468052515), received between May 14, 2020 and Apr 11, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (3 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.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Information1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2024Break; Break
THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2024. IT WAS REPORTED THAT DURING A SIX-MONTH SURGICAL FOLLOW-UP A SYSTEM PEDICLE SCREW WAS IDENTIFIED AS HAVING MALFUNCTIONED. AN XRAY IMAGE WAS PROVIDED OF THE REPORTED IMPLANT DEFICIENCY, WHICH APPEARED TO SHOW THE SHANK OF THE PEDICLE SCREW WAS BROKEN NEAR THE IMPLANT SCREW TULIP. THE BROKEN PEDICLE SCREW AND ROD CONSTRUCT WAS REMOVED DURING A REVISION PROCEDURE AND REPLACED WITHOUT ANY KNOWN INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19088836 ↗InjuryMay 22, 2020Break; Break
IT WAS REPORTED TO RTI SURGICAL ON (B)(6) 2020 THAT TWO STREAMLINE MIS PEDICLE SCREWS BROKE "MONTHS AFTER SURGERY". THE SCREWS WERE DISCOVERED TO BE BROKEN ON (B)(6) 2019. INDEX AND REVISION SURGERY DATES ARE UNKNOWN.
Patient problems: No Information
MAUDE report 10082670 ↗InjuryMay 14, 2020Break; Break
A REVISION SURGERY TOOK PLACE ON (B)(6) 2019 TO REMOVE BROKEN HARDWARE. INDEX SURGERY WAS PERFORMED ON (B)(6) 2017. THE PATIENT REPORTED PAIN IN (B)(6) OF 2018 WHERE "THERE WAS EVIDENCE OF L5-S1 INTERVERTEBRAL HARDWARE SUBSIDENCE PROJECTING INTO THE INTERIOR L5 VERTEBRAL BODY."
Patient problems: Pain
MAUDE report 10058384 ↗
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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