FDA Adverse Event
Injury
Summary report: N
MERCURY SPINAL SYSTEM
MDR report key: 1508193
·
Received October 14, 2009
Report
- Report Number
- 3004893332-2009-00010
- Event Type
- Injury
- Date Received
- October 14, 2009
- Date of Event
- September 28, 2009
- Report Date
- October 8, 2009
- Manufacturer
- SPINAL ELEMENTS, INC.
- Product Code
- MNI
- PMA / PMN Number
- K083230
- 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 A THREADED CAP TO BE DISASSEMBLED FROM THE SCREW ON FILMS TAKEN DURING A FOLLOW-UP EXAM. A REVISION SURGERY WAS PERFORMED IN 2009 TO RE-STABILIZE THE CONSTRUCT. THE REVISION CASE WAS COMPLETED WITH NO FURTHER INCIDENCES. THE PT IS REPORTED TO BE IN GOOD HEALTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MERCURY SPINAL SYSTEM | MNI | SPINAL ELEMENTS, INC. | 62065-040 | 080564 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |