FDA Adverse Event
Injury
Summary report: N
PIONEER SURGICAL TECHNOLOGY
MDR report key: 16952529
·
Received May 18, 2023
Report
- Report Number
- 1833824-2023-00031
- Event Type
- Injury
- Date Received
- May 18, 2023
- Date of Event
- April 26, 2023
- Report Date
- May 18, 2023
- Manufacturer
- PIONEER SURGICAL TECHNOLOGY
- Product Code
- NKB
- PMA / PMN Number
- K192800
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
DEVICE WAS NOT RETURNED TO RESOLVE SURGICAL FOR INSPECTION. BATCH INFORMATION REMAINS UNKNOWN AT THIS TIME. MULTIPLE ATTEMPTS WERE MADE TO GATHER DATA FROM THE REP. NO ADDITIONAL INFORMATION OR CONFIRMATION HAS BEEN GIVEN THAT THIS IS A PIONEER SURGICAL TECHNOLOGIES MANUFACTURED PART.
Description of Event or Problem · 0
OUR DISTRIBUTION PARTNER SURGALIGN REPORTED THAT "RADIOLUCENCY IS OBSERVED IN SCREW L4. TAC IS INDICATED TO DETERMINE IF THERE IS MOBILITY OF THE SCREW.".POSSIBLE PSEUDARTHROSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1894863 | PIONEER SURGICAL TECHNOLOGY | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM | NKB | PIONEER SURGICAL TECHNOLOGY | 01-PA-65-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |