FDA Adverse Event
Injury
Summary report: N
ATOMIC ANTERIOR CERVICAL PLATE SYSTEM
MDR report key: 1051091
·
Received May 22, 2008
Report
- Report Number
- 3004893332-2008-00009
- Event Type
- Injury
- Date Received
- May 22, 2008
- Date of Event
- May 9, 2008
- Report Date
- May 14, 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
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE ATTENDING PHYSICIAN OBSERVED TWO SCREWS BACKING OUT FROM AN ANTERIOR CERVICAL PLATE ON FILMS TAKEN DURING A FOLLOW-UP EXAM. A REVISION SURGERY WAS PERFORMED IN 2008 TO REMOVE AND REPLACE BOTH SCREWS THAT WERE BACKING OUT. THE REVISION CASE WAS COMPLETED WITH NO FURTHER INCIDENCES. THE PT 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. | 25140-016 | 060570 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | MODEL # 25145-016 |