FDA Adverse Event
Injury
Summary report: N
EBI ARRAY SPINAL SYSTEM
MDR report key: 1013596
·
Received March 14, 2008
Report
- Report Number
- 2242816-2008-00033
- Event Type
- Injury
- Date Received
- March 14, 2008
- Date of Event
- January 22, 2008
- Report Date
- March 3, 2008
- Manufacturer
- EBI
- Product Code
- MNI
- PMA / PMN Number
- K061978
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CATALOG # 94640, LOT # 219315. DEVICE MFR DATE: 09/2005.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE FOLLOW UP X-RAY INDICATED BROKEN SCREWS. THE SCREWS WERE EXPLANTED AND NEW SCREWS WERE PLACED. PATIENT HAS RETURNED TO WORK AND RESUMED NORMAL ACTIVITIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EBI ARRAY SPINAL SYSTEM | MNI | EBI | 163930 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |