FDA Adverse Event
Injury
Summary report: N
KYPHX HV-R BONE CEMENT
MDR report key: 1000422
·
Received February 21, 2008
Report
- Report Number
- 2953769-2008-00007
- Event Type
- Injury
- Date Received
- February 21, 2008
- Date of Event
- January 4, 2008
- Report Date
- January 10, 2008
- Manufacturer
- MEDTRONIC SPINE LLC
- Product Code
- NDN
- PMA / PMN Number
- K033801
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD - OTHER; DEVICE NOT RETURNED, FOLLOW UP CONVERSATION WITH COMPANY REPRESENTATIVE AND REPORTING PHYSICIAN.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A KYPHOPLASTY PERFORMED AT LEVELS T10, T11 FOR TRAUMATIC FRACTURES FROM A SNOWBOARDING ACCIDENT THERE WAS A POSTERIOR CEMENT LEAK INTO THE PT'S SPINAL CANAL RESULTING IN A NEUROLOGICAL DEFICIT. THE PHYSICIAN REPORTED THAT THE PT WAS REGAINING SOME MOVEMENT ON THE LEFT SIDE BUT MAY HAVE A PERMANENT DEFICIT ON THE RIGHT SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KYPHX HV-R BONE CEMENT | HIGH VISCOSITY, RADIOPAQUE BONE CEMENT | NDN | MEDTRONIC SPINE LLC | NA | EL19207 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Disability |