FDA Adverse Event
Injury
Summary report: N
CHARLOTTE SMALL MTP FUSION PLATE
MDR report key: 1230243
·
Received November 13, 2008
Report
- Report Number
- 1043534-2008-00321
- Event Type
- Injury
- Date Received
- November 13, 2008
- Date of Event
- October 24, 2008
- Report Date
- October 24, 2008
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HRS
- PMA / PMN Number
- K042205
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. ADD'L INFO HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. THE EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED, WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN ANOTHER COUNTRY.
Description of Event or Problem · 1
ALLEGEDLY, PLATE BROKE DURING NORMAL DAY TO DAY ACTIVITIES, AND CAUSED PAIN IN THE PT. PLATE WAS REMOVED, BUT SURGEON WAS HAPPY WITH THE LEVEL OF HEALING HE SAW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHARLOTTE SMALL MTP FUSION PLATE | HRS | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | 086372031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| R |