Streamline® OCT Occipito-Cervico-Thoracic System 26-FNLDRIVER-2Recalls & reported problems
Pioneer Surgical Technology, Inc. · FINAL LOCKER · Class 1
All models of Streamline OCT Occipito-Cervico-Thoracic System (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846468079697), received between Sep 12, 2025 and Sep 12, 2025 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2025Break; Break
THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 08/15/2025. IT WAS REPORTED THAT TWO DRIVERS WERE DAMAGED AFTER BEING USED TO REMOVE INSTRUMENTATION THAT WAS IMPLANTED THREE YEARS AGO. IT WAS CONFIRMED THAT THIS INSTRUMENT REMOVAL WAS NORMAL COURSE OF TREATMENT FOR THE PATIENT. ALTERNATE REMOVAL TOOLS WERE USED TO SUCCESSFULLY COMPLETE THE SURGERY. THERE WAS NO DELAY IN SURGERY AND NO KNOWN PATIENT COMPLICATIONS. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR THE RETURN OF THE COMPLAINT DRIVERS, HOWEVER THEY WERE NOT RETURNED TO THE MANUFACTURER AFTER MULTIPLE ATTEMPTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23039553 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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