FDA Adverse Event
Injury
Summary report: N
CAPSURE PS SET SCREW
MDR report key: 3161584
·
Received May 7, 2013
Report
- Report Number
- 3004638600-2013-00007
- Event Type
- Injury
- Date Received
- May 7, 2013
- Date of Event
- May 1, 2013
- Report Date
- May 10, 2013
- Manufacturer
- SPINE WAVE, INC.
- Product Code
- MNI
- PMA / PMN Number
- K081228
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT AVAILABLE FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT A LOOSE SET SCREW WAS NOTED ONE MONTH POST-OPERATIVELY FOLLOWING A PEDICLE SCREW CONSTRUCT EXTENSION USING ILIAC SCREWS. THE PATIENT UNDERWENT SURGERY TO REMOVE AND REPLACE THE SET SCREW. THE SURGERY WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200043 | CAPSURE PS SET SCREW | PEDICLE SCREW SYSTEM | MNI | SPINE WAVE, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |