FDA Adverse Event
Other
Summary report: N
HALLU-C PLATE SIZE 1 LEFT
MDR report key: 1414776
·
Received July 14, 2009
Report
- Report Number
- 9615741-2009-00021
- Event Type
- Other
- Date Received
- July 14, 2009
- Date of Event
- July 1, 2009
- Report Date
- July 14, 2009
- Manufacturer
- NEWDEAL S.A.
- Product Code
- HRS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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
THE REPORTER STATED THAT THE DEVICE WAS IMPLANTED ON (B)(6) 2009 HAS BROKEN AND THE PT HAS HAD REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HALLU-C PLATE SIZE 1 LEFT | NA | HRS | NEWDEAL S.A. | ECV2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |