STREAMLINE™* TL SPINAL FIXATION SYSTEM 01-PA-65-40Recalls & reported problems
Pioneer Surgical Technology, Inc. · PEDICLE 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846468005641), received between Feb 19, 2024 and Feb 19, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Improper or Incorrect Procedure or Method2
- Off-Label Use2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2024Break; Off-Label Use; Improper or Incorrect Procedure or Method; Break; Off-Label Use; Improper or Incorrect Procedure or Method
OUR OEM DISTRIBUTION PARTNER "XTANT MEDICAL HAS RECEIVED A PRODUCT COMPLAINT FROM THE STREAMLINE TL SPINAL FIXATION SYSTEM, IN WHICH IT WAS REPORTED THAT TWO 6.5 X 40MM SCREW IMPLANTS (UNKNOWN PRODUCT CODE, LOTS 380167T AND 387549T IDENTIFIED DURING 1/24/24 REVISION PROCEDURE) WERE IDENTIFIED AS BROKEN WHICH REQUIRED A REVISION PROCEDURE. XTANT MEDICAL HAS INITIATED COMPLAINT (B)(4) ON THE ISSUE. ATTACHED IS THE IMAGING PROVIDED BY THE COMPLAINT SOURCE. BELOW IS RELEVANT INFORMATION PROVIDED BY THE COMPLAINT SOURCE, PLEASE LET ME KNOW IF YOU HAVE ANY QUESTIONS OR CONCERNS, APPRECIATE THE ASSISTANCE. INDEX PROCEDURE L4-L5 PERFORMED (B)(6) 2020. ADDITIONAL PROCEDURE FOR EXTENSION OF FUSION TO S1 ON (B)(6) 2023. S1 SCREWS MALFUNCTIONED SOMETIME BETWEEN SEPTEMBER AND DECEMBER OF 2023. REVISION PROCEDURE FOR" XTANT MEDICAL HAS RECEIVED A PRODUCT COMPLAINT FROM THE STREAMLINE TL SPINAL FIXATION SYSTEM, IN WHICH IT WAS REPORTED THAT TWO 6.5 X 40MM SCREW IMPLANTS (UNKNOWN PRODUCT CODE, LOTS 380167T AND 387549T IDENTIFIED DURING (B)(6) 2024 REVISION PROCEDURE) WERE IDENTIFIED AS BROKEN WHICH REQUIRED A REVISION PROCEDURE. XTANT MEDICAL HAS INITIATED COMPLAINT (B)(4) ON THE ISSUE. ATTACHED I
Patient problems: Failure of Implant
MAUDE report 18731459 ↗InjuryFeb 19, 2024Break; Off-Label Use; Improper or Incorrect Procedure or Method; Break; Off-Label Use; Improper or Incorrect Procedure or Method
OUR OEM DISTRIBUTION PARTNER "XTANT MEDICAL HAS RECEIVED A PRODUCT COMPLAINT FROM THE STREAMLINE TL SPINAL FIXATION SYSTEM, IN WHICH IT WAS REPORTED THAT TWO 6.5 X 40MM SCREW IMPLANTS (UNKNOWN PRODUCT CODE, LOTS 380167T AND 387549T IDENTIFIED DURING (B)(6) 2024 REVISION PROCEDURE) WERE IDENTIFIED AS BROKEN WHICH REQUIRED A REVISION PROCEDURE. XTANT MEDICAL HAS INITIATED COMPLAINT 24-008 ON THE ISSUE. ATTACHED IS THE IMAGING PROVIDED BY THE COMPLAINT SOURCE. BELOW IS RELEVANT INFORMATION PROVIDED BY THE COMPLAINT SOURCE, PLEASE LET ME KNOW IF YOU HAVE ANY QUESTIONS OR CONCERNS, APPRECIATE THE ASSISTANCE. -INDEX PROCEDURE L4-L5 PERFORMED OCTOBER 2020 -ADDITIONAL PROCEDURE FOR EXTENSION OF FUSION TO S1 ON (B)(6), 2023 -S1 SCREWS MALFUNCTIONED SOMETIME BETWEEN SEPTEMBER AND DECEMBER OF 2023 -REVISION PROCEDURE FOR" XTANT MEDICAL HAS RECEIVED A PRODUCT COMPLAINT FROM THE STREAMLINE TL SPINAL FIXATION SYSTEM, IN WHICH IT WAS REPORTED THAT TWO 6.5 X 40MM SCREW IMPLANTS (UNKNOWN PRODUCT CODE, LOTS 380167T AND 387549T IDENTIFIED DURING 1/24/24 REVISION PROCEDURE) WERE IDENTIFIED AS BROKEN WHICH REQUIRED A REVISION PROCEDURE. XTANT MEDICAL HAS INITIATED COMPLAINT (B)(4) ON THE ISSUE. ATTACHE
Patient problems: Failure of Implant
MAUDE report 18731447 ↗
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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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