FDA Adverse Event
Malfunction
Summary report: N
CENTRAX DURATION 22.2MM X 40MM
MDR report key: 2962112
·
Received January 22, 2013
Report
- Report Number
- 2249697-2013-90162
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Date of Event
- December 27, 2012
- Report Date
- December 27, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K780318
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
DURING SURGERY, RIGHT AFTER THE PACKAGE WAS OPENED, IT WAS FOUND THAT THE OUTER RING HAD BEEN DISASSOCIATED. A BACKUP DEVICE WAS USED. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31575 | CENTRAX DURATION 22.2MM X 40MM | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | A09S522 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |