FDA Adverse Event
Injury
Summary report: N
2520274-2013-02462
MDR report key: 3101794
·
Received May 9, 2013
Report
- Report Number
- 2520274-2013-02462
- Event Type
- Injury
- Date Received
- May 9, 2013
- Report Date
- April 12, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A PATIENT WAS TREATED ON AN UNKNOWN DATE WITH AN ANTEROLATERAL PLATE FOR A DISTAL TIBIAL FRACTURE. IT WAS REPORTED THAT THE PLATE BROKE POST-OPERATIVELY AND THE FRACTURE DID NOT HEAL. A REVISION SURGERY IS PLANNED FOR AN UNKNOWN DATE FOR THE FIXATION OF THE FRACTURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204599 | HRS | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |