FDA Adverse Event
Injury
Summary report: N
DYNA-LOK CLASSIC SPINAL SYSTEM
MDR report key: 10571338
·
Received September 23, 2020
Report
- Report Number
- 1030489-2020-01329
- Event Type
- Injury
- Date Received
- September 23, 2020
- Report Date
- September 23, 2020
- Manufacturer
- WARSAW ORTHOPEDICS
- Product Code
- NKB
- PMA / PMN Number
- K050439
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH FUSION THERAPY. IT WAS REPORTED THAT THE DY-C ON L4-5 WAS REMOVED AND PLIF ON L5-S1 WAS ADDED. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1037483 | DYNA-LOK CLASSIC SPINAL SYSTEM | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE | NKB | WARSAW ORTHOPEDICS | 7436540 | 0126437W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |