PIONEER SURGICAL TECHNOLOGY STREAMLINE TL
Report
- Report Number
- 1833824-2024-00027
- Event Type
- Injury
- Date Received
- February 19, 2024
- Report Date
- May 16, 2024
- Manufacturer
- PIONEER SURGICAL TECHNOLOGY
- Product Code
- NKB
- UDI-DI
- 00846468005573
- PMA / PMN Number
- K140696
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
DEVICE WAS NOT RETURNED TO RESOLVE SURGICAL FOR INSPECTION. MULTIPLE ATTEMPTS WERE MADE TO GATHER DATA FROM THE REP AS. NO ADDITIONAL INFORMATION OR CONFIRMATION HAS BEEN GIVEN THAT THIS IS A PIONEER SURGICAL TECHNOLOGIES MANUFACTURED PART. THE FOLLOWING SECTIONS OF THIS REPORT HAVE BEEN LEFT BLANK DUE TO THE INFORMATION BEING UNAVAILABLE OR NON-APPLICABLE.
DEVICE WAS NOT RETURNED TO RESOLVE SURGICAL FOR INSPECTION. MULTIPLE ATTEMPTS WERE MADE TO GATHER DATA FROM THE REP AS. NO ADDITIONAL INFORMATION OR CONFIRMATION HAS BEEN GIVEN THAT THIS IS A PIONEER SURGICAL TECHNOLOGIES MANUFACTURED PART.
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" .
OUR OEM DISTRIBUTION 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 24-009 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 (B)(6) 2024. REVISION PROCEDURE PLANNED TO REMOVE BROKEN SCREWS AND INNER BODY BECAUSE THE CAGE IS DISPLACED AND GOING INTO THE SPINAL CANAL, DATE TBD" . INFORMATION ON THE REVISION "(B)(6) 2024 EXPLANTATION OF L5 HARDWARE, SET SCREWS, AND RODS. PLACEMENT OF PEDICLE SCREWS, BILATERAL S1. EXPLANTATION OF PROTRUDING RIGHT L4-5 INTERBODY GRAFT. RIGHT L4-5 FACETECTOMY. L4-5 INTERBODY FUSION USING TRINITY AND MORCELLATED AUTOGRAFT. POSTERIOR INSTRUMENTATION AND FUSION L4-5, L5-S1 BILATERALLY USING RTI PEDICLE SCREWS AND RODS. POSTEROLATERAL FUSION BILATERAL L4-5, L5-S1 USING TRINITY AND MORCELLATED AUTOGRAFT".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 389411 | PIONEER SURGICAL TECHNOLOGY STREAMLINE TL | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM | NKB | PIONEER SURGICAL TECHNOLOGY | 01-PA-55-45 | 371916 | 00846468005573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |