FDA Adverse Event
Summary report: N
EBI SPINELINK SPINAL FIXATION SYSTEM
MDR report key: 1162924
·
Received September 18, 2008
Report
- Report Number
- 2242816-2008-00130
- Date Received
- September 18, 2008
- Date of Event
- August 13, 2008
- Report Date
- September 9, 2008
- Manufacturer
- EBI, L.P.
- Product Code
- NKB
- PMA / PMN Number
- K031424
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DHR REVIEW OF THE RELATED DEVICE FOUND NO DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. "BENDING, FRACTURE, LOOSENING OR MIGRATION OF THE IMPLANT" ARE LISTED AS POSSIBLE ADVERSE EFFECTS ON THE PACKAGE INSERT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BROKEN SCREW WAS REMOVED FROM THE LEFT S1 PEDICLE. THE PATIENT WAS FUSED PRIOR TO REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EBI SPINELINK SPINAL FIXATION SYSTEM | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE | NKB | EBI, L.P. | 391270 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |