FDA Adverse Event
Malfunction
Summary report: N
2520274-2013-02326
MDR report key: 3091615
·
Received May 3, 2013
Report
- Report Number
- 2520274-2013-02326
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Report Date
- April 5, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- FSM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.
Additional Manufacturer Narrative · 1
AFTER FURTHER REVIEW BY POST MARKET RISK MANAGER, THIS EVENT HAS BEEN DEEMED NON-REPORTABLE. PLACEHOLDER.
Description of Event or Problem · 1
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IT WAS DISCOVERED THAT A COLOR CODING DEPTH CHART FOR CALIBRATED DRILLS DID NOT MATCH THE COLOR CODING ON THE CALIBRATED DRILLS. THE DRILLS WERE SWAPPED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194398 | FSM | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |