FDA Adverse Event
Injury
Summary report: N
INBONE TALAR DOME
MDR report key: 1172079
·
Received September 23, 2008
Report
- Report Number
- 1043534-2008-00246
- Event Type
- Injury
- Date Received
- September 23, 2008
- Date of Event
- August 25, 2008
- Report Date
- August 25, 2008
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HSN
- PMA / PMN Number
- K051023
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ATTEMPTS HAVE BEEN MADE TO HAVE THE PRODUCT RETURNED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2008-00243, 00244, 00245, AND 00247
Description of Event or Problem · 1
ALLEGEDLY PATIENT REVISED TO ANOTHER COMPANY'S PRODUCT - FUSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INBONE TALAR DOME | HSN | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Hospitalization| R |