Streamline™* MIS Spinal Fixation System 05-PA-75-50Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846468052539), received between Apr 9, 2020 and Apr 9, 2020 — classified as 1 injury.
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
Patient problems
- Intraoperative Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
(B)(6) REPORTED INCIDENT - APPROXIMATELY 6 WEEKS POST-OP, THE PATIENT REPORTED PAIN DUE TO A 2 LEVEL SURGERY FROM L4 TO S1 WITH A TLIF APPROACH WITH CAGE ON THE LEFT SIDE FROM L5/S1. IT WAS DISCOVERED THROUGH X-RAY THAT HEAD OF THE SCREW AT S1 ON THE RIGHT SIDE POPPED OFF. REVISION SURGERY WAS CONDUCTED ON AN UNKNOWN DATE, AND TYPE OF RECONSTRUCTION IS UNDETERMINED AS OF REPORTING DATE.
Patient problems: Intraoperative Pain
MAUDE report 9943378 ↗
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- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
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- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
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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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