Streamline OCT Occipito-Cervico-Thoracic SystemRecalls & reported problems across all models
Pioneer Surgical Technology, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 4 models of Streamline OCT Occipito-Cervico-Thoracic System by Pioneer Surgical Technology, Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Mar 7, 2016 and Sep 12, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Streamline OCT Occipito-Cervico-Thoracic System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 16, 2016Terminated
RTI Surgical Inc. (RTI) is conducting a voluntary recall on two specific lots of the Streamline OCT Straight Rod, CoCr. 3.2mm (D) x 240mm (L) due to the potential for small cracks to be present on the rods. The small cracks on the rods used in implants could cause reduced strength of these affected implants, and lead to patient injury.
Z-0290-2017 · Root cause: Process control · Recall details · FDA record ↗
Most reported Streamline OCT Occipito-Cervico-Thoracic System problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Streamline OCT Occipito-Cervico-Thoracic System models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- STREAMLINE®* OCT OCCIPITO-CERVICO-THORACIC SYSTEM 23-CC-ROD-240APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall0 reports
- Streamline® OCT Occipito-Cervico-Thoracic System 26-FNLDRIVERORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Streamline® OCT Occipito-Cervico-Thoracic System 26-R2R-XLINK-DRVRORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Streamline® OCT Occipito-Cervico-Thoracic System 26-FNLDRIVER-2ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent Streamline OCT Occipito-Cervico-Thoracic System adverse event reports
The 3 most recent reports across all models, 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 ↗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 23039540 ↗MalfunctionMar 7, 2016Break; Break
DURING A POSTERIOR OCCIPITO-CERVICO-THORACIC FUSION SURGERY, THE FINAL SET SCREW DRIVER TIP BROKE OFF IN THE SET SCREW. THIS WAS NOT ABLE TO BE REMOVED AND REMAINS IN THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5484798 ↗
Other Pioneer Surgical Technology, Inc. products
All Pioneer Surgical Technology, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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