FDA Adverse Event
Other
Summary report: N
NEURAL INTEGRITY MONITORING SPINE SYSTEM
MDR report key: 1422967
·
Received July 27, 2009
Report
- Report Number
- 1030489-2009-00701
- Event Type
- Other
- Date Received
- July 27, 2009
- Date of Event
- June 7, 2009
- Report Date
- June 7, 2009
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- ETN
- PMA / PMN Number
- K031003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). NO PRODUCT WAS RETURNED FOR EVAL. WITH THE AVAILABLE INFO, A CAUSE OR CONTRIBUTING FACTOR CANNOT BE IDENTIFIED.
Description of Event or Problem · 1
IT WAS REPORTED THAT FRAGMENTS OF THE PEDICLE NEEDLE COATING DETACHED FROM THE NEEDLE. THE FRAGMENTS WERE LEFT IN THE PT. NO REVISION SURGERY WAS NEEDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEURAL INTEGRITY MONITORING SPINE SYSTEM | NEEDLE | ETN | WARSAW ORTHOPEDIC INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |