FDA Adverse Event
Other
Summary report: N
TREL-XC PUTTY 5CC
MDR report key: 1627903
·
Received March 9, 2010
Report
- Report Number
- 2090010-2010-00001
- Event Type
- Other
- Date Received
- March 9, 2010
- Date of Event
- March 1, 2010
- Report Date
- March 9, 2010
- Manufacturer
- ISOTIS ORTHOBIOLOGICS, INC.
- Product Code
- MQV
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE DEVICE WAS IMPLANTED DURING A SURGICAL PROCEDURE FOR A CALCANEAL FRACTURE. THE PRODUCT HAD EXCEEDED THE LABEL EXPIRATION DATE BY ONE DAY AT THE TIME THAT IT WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TREL-XC PUTTY 5CC | NA | MQV | ISOTIS ORTHOBIOLOGICS, INC. | 080149 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other | ORTHOPEDIC STABILIZATION PLATE |