FDA Adverse Event
Injury
Summary report: N
STAXX XD
MDR report key: 2161730
·
Received July 8, 2011
Report
- Report Number
- 3004638600-2011-00006
- Event Type
- Injury
- Date Received
- July 8, 2011
- Date of Event
- December 10, 2010
- Report Date
- June 9, 2011
- Manufacturer
- SPINE WAVE, INC.
- Product Code
- MQP
- PMA / PMN Number
- K052670
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO: THE EXPLANTED DEVICE WAS RETURNED FOR EVAL. THE CONSTRUCT WAS RETURNED INTACT. VISUAL EXAMINATION WAS PERFORMED AND NO ABNORMALITIES WERE OBSERVED OTHER THAN DAMAGE WHICH IS CONSISTENT WITH REMOVAL METHODS. NO CONCLUSION CAN BE DRAWN BASED ON EVAL OF THE RETURNED DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT UNDERWENT SURGERY TO REMOVE THE CONSTRUCT AFTER IT WAS DETERMINED THAT THE CONSTRUCT HAD MIGRATED. THE SURGERY WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAXX XD | SPINAL VERTEBRAL BODY REPLACEMENT | MQP | SPINE WAVE, INC. | NA | 273G62 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |