STREAMLINE™* TL SPINAL FIXATION SYSTEM 01-PA-55-45Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00846468005573), received between Feb 19, 2024 and Mar 7, 2024 — classified as 3 injuries.
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
- Improper or Incorrect Procedure or Method2
- Off-Label Use2
Patient problems
- Failure of Implant3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 7, 2024Break; Off-Label Use; Improper or Incorrect Procedure or Method; Break; Off-Label Use; Improper or Incorrect Procedure or Method
OUR OEM DISTRIBUTION REP "XTANT MEDICAL HAS RECEIVED A PRODUCT COMPLAINT FROM THE STREAMLINE TL SPINAL FIXATION SYSTEM, IN WHICH IT WAS REPORTED THAT TWO PEDICLE SCREW IMPLANTS (01-PA-55-45, LOTS 378753 AND 388226) WERE IDENTIFIED AS BROKEN, WHICH REQUIRED A REVISION PROCEDURE. XTANT MEDICAL HAS INITIATED COMPLAINT 24-024 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 PERFORMED (B)(6) 2022. REVISION PROCEDURE PERFORMED (B)(6) 2024".
Patient problems: Failure of Implant
MAUDE report 18859264 ↗InjuryMar 7, 2024Break; Off-Label Use; Improper or Incorrect Procedure or Method; Break; Off-Label Use; Improper or Incorrect Procedure or Method
OUR OEM DISTRIBUTION REP "XTANT MEDICAL HAS RECEIVED A PRODUCT COMPLAINT FROM THE STREAMLINE TL SPINAL FIXATION SYSTEM, IN WHICH IT WAS REPORTED THAT TWO PEDICLE SCREW IMPLANTS (01-PA-55-45, LOTS 378753 AND 388226) WERE IDENTIFIED AS BROKEN, WHICH REQUIRED A REVISION PROCEDURE. XTANT MEDICAL HAS INITIATED COMPLAINT 24-024 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 PERFORMED (B)(6) 2022, REVISION PROCEDURE PERFORMED (B)(6) 2024".
Patient problems: Failure of Implant
MAUDE report 18859262 ↗InjuryFeb 19, 2024Break; Break
OUR OEM DISRTIBUTION REP STATED ""XTANT MEDICAL HAS RECEIVED A PRODUCT COMPLAINT FROM THE STREAMLINE TL SPINAL FIXATION SYSTEM, IN WHICH IT WAS REPORTED THAT TWO 5.5MM DIAMETER SCREW IMPLANTS (UNKNOWN PRODUCT CODE/LOT NUMBER) WERE IDENTIFIED AS BROKEN WHICH WILL REQUIRE 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. I AM HOPING TO GATHER SOME ADDITIONAL INCIDENT AND PRODUCT INFORMATION UPON COMPLETION OF THE REVISION PROCEDURE, WHICH HAS YET TO OCCUR BUT WILL PROVIDE ANY ADDITIONAL INFORMATION GATHERED. -INDEX PROCEDURE L4-L5 TLIF PERFORMED (B)(6) 2021. -L5 SCREWS MALFUNCTIONED JANUARY 2024. -REVISION PROCEDURE PLANNED TO REMOVE BROKEN SCREWS AND INNER BODY BECAUSE THE CAGE IS DISPLACED AND GOING INTO THE SPINAL CANAL, DATE TBD" .
Patient problems: Failure of Implant
MAUDE report 18731509 ↗
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- 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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