FDA Adverse Event
Malfunction
Summary report: N
GOLDEN ISLES PEDICLE SCREW SYSTEM
MDR report key: 22009694
·
Received May 13, 2025
Report
- Report Number
- 3019356409-2025-00001
- Event Type
- Malfunction
- Date Received
- May 13, 2025
- Date of Event
- April 25, 2025
- Report Date
- May 12, 2025
- Manufacturer
- INTELIVATION TECHNOLOGIES, LLC
- Product Code
- NKB
- PMA / PMN Number
- K212185
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
FOLLOWED UP WITH DOCTOR REGARDING THE PATIENT STATE. HE STATED THAT THE PATIENT IS DOING WELL AND HE DOESN'T THINK THAT THE EVENT WILL AFFECT HER IN ANY WAY. HE ALSO STATED THAT THE ERROR WAS HIS BECAUSE HIS TECHNIQUE IS A LITTLE DIFFERENT FROM WHAT'S DESCRIBED IN THE IFU.
Additional Manufacturer Narrative · 0
INVESTIGATION TEAM FOLLOWED UP WITH DOCTOR ON (B)(6) 2025. DR STATED THAT THE DETACHMENT IS DUE TO HIS TECHNIQUE AND WILL NOT CONDUCT ANY CORRECTION AS PATIENT IS HEALING WELL DESPITE THE DETACHMENT.
Description of Event or Problem · 0
POST OPERATIVE X-RAY SHOWED THAT THE TWO SUPERIOR SET SCREWS WERE DISENGAGED FROM THE TULIPS HEADS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 719153 | GOLDEN ISLES PEDICLE SCREW SYSTEM | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM | NKB | INTELIVATION TECHNOLOGIES, LLC | C51-0000-A00 / C51-1000-A03 | SEE UDI SECTION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Other |