FDA Adverse Event
Other
Summary report: N
PARALLAX EZ FLOW CEMENT DELIVERY SYSTEM
MDR report key: 1960264
·
Received January 7, 2011
Report
- Report Number
- 2951580-2011-00003
- Event Type
- Other
- Date Received
- January 7, 2011
- Date of Event
- December 1, 2010
- Report Date
- January 7, 2011
- Manufacturer
- ARTHROCARE CORPORATION
- Product Code
- OAR
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DATE OF THE EVENT IS NOT KNOWN AND PROVIDED AS AN APPROXIMATE DATE OF EVENT. AWAITING FURTHER INFORMATION IF THE DEVICE WILL BE RETURNED FOR INVESTIGATION. TWO DEVICES WERE USED IN THE SAME PROCEDURE. THE SECOND DEVICE WAS FILED UNDER MEDWATCH NO 2951580-2011-00004.
Description of Event or Problem · 1
DURING A VERTEBROPLASTY PROCEDURE WITH THE PARALLAX EZ FLOW CEMENT DELIVERY SYSTEM AND PARALLAX ACRYLIC RESIN WITH TRACERS - TA, THE PARALLAX EZ FLOW CEMENT DELIVERY SYSTEM EXPLODED DURING THE DELIVERY OF THE CEMENT (PARALLAX ACRYLIC RESIN WITH TRACERS-TA). THERE WAS NO REPORTED INJURY TO THE PT. THE PROCEDURE WAS NOT COMPLETED AND WILL BE RESCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARALLAX EZ FLOW CEMENT DELIVERY SYSTEM | CEMENT INJECTOR | OAR | ARTHROCARE CORPORATION | M201992 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |