FDA Adverse Event
Malfunction
Summary report: N
OSV II
MDR report key: 2220084
·
Received August 9, 2011
Report
- Report Number
- 9612007-2011-00029
- Event Type
- Malfunction
- Date Received
- August 9, 2011
- Date of Event
- June 23, 2011
- Report Date
- August 9, 2011
- Manufacturer
- INTEGRA, BIOT
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
AN OSVII WAS IMPLANTED IN (B)(6) 2010. ON (B)(6) 2011, THE PT REQUIRED REVISION SURGERY THAT INCLUDED EXPLANTING THE OSVII. THE REASON FOR THE EXPLANTATION AND REVISION WERE NOT PROVIDED. THE OSVII WAS REPLACED WITH A MEDTRONIC PERITONEAL VALVE. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OSV II | OSV II | JXG | INTEGRA, BIOT | 0156915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR |