FDA Adverse Event
Injury
Summary report: N
KYPHX BONE FILLER DEVICE
MDR report key: 475338
·
Received July 30, 2003
Report
- Report Number
- 2953769-2003-00008
- Event Type
- Injury
- Date Received
- July 30, 2003
- Date of Event
- June 23, 2003
- Report Date
- July 1, 2003
- Manufacturer
- KYPHON INC.
- Product Code
- KIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT'S INJURIES INCLUDED FRACTURES OF L1 AND L2. THE FRACTURES WERE REDUCED USING THE KYPHX SYSTEM AND FIXATION WAS DONE USING PMMA CEMENT (TYPE UNKNOWN). THERE ARE NO DETAILS OF THE PROCEDURE AVAILABLE; HOWEVER, THE PT WAS SEEN BY THE REPORTING NEUROSURGEON ONE WEEK AFTER THE PROCEDURE FOR LEG PAIN. PT'S EVAL REVEALED X-RAY EVIDENCE OF A PMMA CEMENT EXTRAVASATION NEAR THE CORD ON THE PT'S RIGHT SIDE, JUST BELOW L1. THE NEUROSURGEON MADE A DIAGNOSIS OF RADICULOPATHY SECONDARY TO THE CEMENT COMPRESSING EITHER THE CORD OR A NERVE ROOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KYPHX BONE FILLER DEVICE | BONE FILLER DEVICE | KIH | KYPHON INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |