FDA Adverse Event
Malfunction
Summary report: N
ARTHROSCOPE
MDR report key: 1920372
·
Received December 10, 2010
Report
- Report Number
- 2953769-2010-00601
- Event Type
- Malfunction
- Date Received
- December 10, 2010
- Date of Event
- November 1, 2010
- Report Date
- November 19, 2010
- Manufacturer
- MEDTRONIC SPINE LLC.
- Product Code
- HRX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED.
Additional Manufacturer Narrative · 1
METHOD - FOLLOWED UP WITH COMPANY REPRESENTATIVE. THIS MDR IS FOR 1 BALLOON. PLEASE REFERENCE MDR FOR OTHER BALLOON AND MDR FOR CEMENT LEAKAGE.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED CONFIRMED NO FRAGMENTS WERE LEFT IN THE PATIENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A KYPHOPLASTY PROCEDURE. DURING THE PROCEDURE, THE TWO BALLOONS BROKE WITH BILATERAL EXTRAVASATION OF THE CONTRAST LIQUID FOLLOWED BY CEMENT LEAKAGE. COULD NOT CONFIRM IF ANY FRAGMENTS OF THE BALLOON WERE LEFT IN THE PATIENT. NO ADDITIONAL INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTHROSCOPE | HRX | MEDTRONIC SPINE LLC. | 0001920080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |