FDA Adverse Event
Injury
Summary report: N
ATOMIC ANTERIOR CERVICAL PLATE SYSTEM
MDR report key: 1053280
·
Received May 28, 2008
Report
- Report Number
- 3004893332-2008-00008
- Event Type
- Injury
- Date Received
- May 28, 2008
- Date of Event
- May 9, 2008
- Report Date
- May 9, 2008
- Manufacturer
- SPINAL ELEMENTS, INC.
- Product Code
- KWQ
- PMA / PMN Number
- K060491
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE ATTENDING PHYSICIAN OBSERVED ONE SCREW BACKING OUT FROM AN ANTERIOR CERVICAL PLATE ON FILMS TAKEN DURING A FOLLOW-UP EXAM. A REVISION SURGERY WAS PERFORMED IN 2008. THE PLATE AND SCREWS WERE EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S SYSTEM. THE REVISION CASE WAS COMPLETED WITH NO FURTHER INCIDENCES. THE PATIENT IS REPORTED TO BE IN GOOD HEALTH AND WILL CONTINUE TO BE MONITORED CLOSELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATOMIC ANTERIOR CERVICAL PLATE SYSTEM | KWQ | SPINAL ELEMENTS, INC. | 25240-012 | 060482 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |