FDA Adverse Event
Malfunction
Summary report: N
2.5MM DRILL BIT/QC/GOLD/110MM
MDR report key: 3540728
·
Received December 28, 2013
Report
- Report Number
- 1719045-2013-02148
- Event Type
- Malfunction
- Date Received
- December 28, 2013
- Report Date
- December 4, 2013
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HTW
- PMA / PMN Number
- K962913
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ADDITIONAL PRODUCT CODE: HSZ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS PLACEHOLDER.
Description of Event or Problem · 1
USER FACILITY MEDWATCH REPORT NUMBER (B)(4) WAS RECEIVED AND A COPY OF THAT REPORT WILL BE INCLUDED IN THIS REPORT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 678823 | 2.5MM DRILL BIT/QC/GOLD/110MM | HTW | SYNTHES MONUMENT | U172609 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |