FDA Adverse Event
Injury
Summary report: N
TI RIB SLEEVE-SIZE 9 220MM RADIUS
MDR report key: 2150499
·
Received June 23, 2011
Report
- Report Number
- 2530088-2011-00158
- Event Type
- Injury
- Date Received
- June 23, 2011
- Report Date
- June 3, 2011
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- MDI
- PMA / PMN Number
- H030009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.
Description of Event or Problem · 1
PATIENT STATUS POST VEPTR IMPLANTATION ON AN UNKNOWN DATE BY A DIFFERENT SURGEON RETURNED TO OPERATING ROOM, SURGEON EXPLANTED VEPTR ON (B)(6) 2011. SURGEON DISCOVERED UPON REMOVAL THAT THE VEPTR TI RIB SLEEVE WAS BROKEN. IT IS NOT KNOWN IF IMPLANT WAS BROKEN ON IMPLANTATION, BROKEN INTRA-OPERATIVELY, AND/OR UPON REMOVAL. PATIENT WAS REVISED TO AN UNKNOWN PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TI RIB SLEEVE-SIZE 9 220MM RADIUS | TI RIB SLEEVE | MDI | SYNTHES BRANDYWINE | NA | 4967981 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |