FDA Adverse Event
Injury
Summary report: N
KYPHX BONE FILLER DEVICE
MDR report key: 512324
·
Received February 20, 2004
Report
- Report Number
- 2953769-2004-00001
- Event Type
- Injury
- Date Received
- February 20, 2004
- Date of Event
- January 27, 2004
- Report Date
- January 30, 2004
- Manufacturer
- KYPHON INC.
- Product Code
- KIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT WAS BEING TREATED FOR THREE VERTEBRAL BODY COMPRESSION FRACTURES USING THE KYPHX SYSTEM AND PMMA BONE CEMENT (BRAND UNKNOWN). THE PROCEDURES WERE TOLERATED WELL UNDER A LOCAL ANESTHESIA. POSTOPERATIVELY THE PT BECAME DYSPNEIC AND HYPOXIC WITH PO2 SATURATIONS OF 70%, AND WAS GIVEN SUPPLEMENTAL OXYGEN. A LUNG SCAN REVEALED NO DIFFUSION DEFECTS, BUT MATERIAL COULD BE SEEN ON A CHEST RADIOGRAPH. REPEAT RADIOGRAPHS OF THE LUMBAR SPINE REVEALED A SMALL AMOUNT OF BONE CEMENT IN THE SPINAL CANAL; HOWEVER THE PT HAS NO NEUROMUSCULAR SYMPTOMS DUE TO THE EXTRAVASATION INTO THE CANAL.
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 | 70 YR | Required Intervention |