FDA Adverse Event
Injury
Summary report: N
HTR-PMI GRIMES RT FRT
MDR report key: 2461573
·
Received February 20, 2012
Report
- Report Number
- 0001032347-2012-00014
- Event Type
- Injury
- Date Received
- February 20, 2012
- Report Date
- February 13, 2012
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- KKY
- PMA / PMN Number
- PK924935
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, 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
THE PATIENT HAD A REVISION SURGERY WHERE THE HTR WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HTR-PMI GRIMES RT FRT | HARD TISSUE REPLACEMENT | KKY | BIOMET MICROFIXATION | N/A | 070230 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |