FDA Adverse Event
Injury
Summary report: N
THE CURVED CDO SYSTEM
MDR report key: 817278
·
Received February 9, 2007
Report
- Report Number
- 2242816-2007-00003
- Event Type
- Injury
- Date Received
- February 9, 2007
- Date of Event
- December 30, 2006
- Report Date
- January 10, 2007
- Manufacturer
- BIOMET
- Product Code
- NDN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
THE CEMENT, PART #619 1 001, LOT #RJN275 X2 USED IN THE PROCEDURE WAS THE REASON FOR THIS REPORT. THE INITIAL REPORT FROM THE MRI WAS THE CEMENT CAUSED THE PT CONDITION, NOT THE DEVICE LISTED IN THE REPORT. THE CEMENT MFG IS DIFFERENT THAN THE MFG SUBMITTING THIS REPORT.
Description of Event or Problem · 1
DOCTOR PERFORMED A VETEBROPLASTY USING ICI CDO SYSTEM AND STRYKER CEMENT. TWO DAYS POST OP, THE PT LOSS THE USE OF HER LEGS AND SEEMS TO BE PARALYZED. AFTER THE HOSP PERFORMED AN MRI, IT WAS CONCLUDED THAT THERE WAS CEMENT IN THE SPINAL CANAL. PT OUTCOME: PARALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THE CURVED CDO SYSTEM | NDN | NDN | BIOMET | * | 245080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention| S |