FDA Adverse Event
Injury
Summary report: N
CONCORDE PROTI 5 DG, 9X9X27 MM
MDR report key: 18163452
·
Received November 17, 2023
Report
- Report Number
- 3012966183-2023-00026
- Event Type
- Injury
- Date Received
- November 17, 2023
- Report Date
- November 17, 2023
- Manufacturer
- TYBER MEDICAL
- Product Code
- MAX
- UDI-DI
- 00819917021295
- PMA / PMN Number
- K172185
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS WAS A TRANSFORAMINAL LUMBAR INTERBODY FUSION (L5/S1) FOR LUMBAR SPINAL CANAL STENOSIS ON (B)(6) 2023. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2023 WITH CONCORDE. AFTER THE SURGERY, THE BACKED OUT OF CONCORDE IN QUESTION WAS CONFIRMED ON AN UNKNOWN DATE. ON (B)(6) 2023, THE SECOND SURGERY WAS PERFORMED TO REMOVE THE SET SCREW (EXPEDIUM VERSE) AND THE ROD AND TO HUMMER THE CONCORDE IN 5 MM. THE SURGEON APPLIED COMPRESSION BETWEEN THE SCREWS. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 917486 | CONCORDE PROTI 5 DG, 9X9X27 MM | INTERBODY SPACERS | MAX | TYBER MEDICAL | 188827409 | 203401 | 00819917021295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |