FDA Adverse Event
Injury
Summary report: N
LCP DISTTIBPL2.7/3.5 MED R SHAFT 8HO SST
MDR report key: 2822870
·
Received November 7, 2012
Report
- Report Number
- 2520274-2012-02992
- Event Type
- Injury
- Date Received
- November 7, 2012
- Date of Event
- December 6, 2008
- Report Date
- October 10, 2012
- Manufacturer
- SYNTHES USA
- Product Code
- HRS
- PMA / PMN Number
- K013248
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH PLATE ON (B)(6) 2007. THE PLATE BROKE POST-OPERATIVE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LCP DISTTIBPL2.7/3.5 MED R SHAFT 8HO SST | PLATE | HRS | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |