FDA Adverse Event
Injury
Summary report: N
ALIQUOT SYRINGE DELIVERY SYSTEM
MDR report key: 2210088
·
Received August 3, 2011
Report
- Report Number
- 2530131-2011-00001
- Event Type
- Injury
- Date Received
- August 3, 2011
- Date of Event
- October 1, 2010
- Report Date
- July 1, 2011
- Manufacturer
- ORTHOVITA, INC.
- Product Code
- NDN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT WAS REPORTED BY STRYKER (B)(4) ON (B)(4) 2011, BUT THE EVENT OCCURRED IN (B)(6) 2010. THIS IS THE FIRST TIME THAT ORTHOVITA HAS BEEN MADE AWARE OF THIS EVENT. THE PHYSICIAN HAS BEEN CONTACTED, BUT HAS NOT YET OFFERED FURTHER INFO OR MET WITH STRYKER REPRESENTATIVES. METHOD: BATCH RECORD REVIEW PERFORMED. NO RELEVANT NON-CONFORMANCES NOTED. CONCLUSION: NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
A PHYSICIAN WAS PERFORMING A VERTEBROPLASTY USING AN ALIQUOT DELIVERY SYSTEM WHEN THE CATHETER OR NEEDLE BROKE DURING REMOVAL AND PART OF THE DEVICE WAS LEFT IN THE PT. THE INVESTIGATION IS ONGOING AND F/U REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFO BECOMES AVAILABLE. THIS EVENT OCCURRED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALIQUOT SYRINGE DELIVERY SYSTEM | DISPENSER, CEMENT | NDN | ORTHOVITA, INC. | 2090-0501 | A1001015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |