FDA Adverse Event
Injury
Summary report: N
PATIENT SPECIFIC IMPLANT
MDR report key: 2070290
·
Received April 19, 2011
Report
- Report Number
- 2530088-2011-00121
- Event Type
- Injury
- Date Received
- April 19, 2011
- Report Date
- March 29, 2011
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- GXN
- PMA / PMN Number
- K033868
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS INFORMATION HAS NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ONGOING, NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
A PATIENT WAS IMPLANTED WITH A 2-PIECE PATIENT SPECIFIC IMPLANT IN (B)(6). POST IMPLANTATION THE PATIENT HAS EXPERIENCED ADVERSE EVENTS. THE PATIENT REPORTEDLY DEVELOPED CONVULSIONS AND A POSSIBLE INFECTION. THIS REPORT IS #1 OF 2 FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PATIENT SPECIFIC IMPLANT | PATIENT SPECIFIC IMPLANT | GXN | SYNTHES BRANDYWINE | NA | 6621438 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |