FDA Adverse Event
Injury
Summary report: N
HTR PMI STOOK
MDR report key: 2082985
·
Received May 10, 2011
Report
- Report Number
- 1032347-2011-00071
- Event Type
- Injury
- Date Received
- May 10, 2011
- Report Date
- April 19, 2011
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- GXN
- PMA / PMN Number
- K924935
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION AND THE HTR IMPLANT WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HTR PMI STOOK | HARD TISSUE REPLACEMENT | GXN | BIOMET MICROFIXATION | 261370 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |