FDA Adverse Event
Malfunction
Summary report: N
CANNULATED DRILL 2 IN 1 DIAM 2.2
MDR report key: 2472977
·
Received February 16, 2012
Report
- Report Number
- 9615741-2012-00007
- Event Type
- Malfunction
- Date Received
- February 16, 2012
- Report Date
- February 16, 2012
- Manufacturer
- NEWDEAL S.A.
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE DRILL BROKE INTO TWO PIECES DURING USE IN A SURGICAL PROCEDURE. INTEGRA HAS REQUESTED ADDITIONAL INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CANNULATED DRILL 2 IN 1 DIAM 2.2 | NA | HTW | NEWDEAL S.A. | EPYC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |