FDA Adverse Event
Malfunction
Summary report: N
301 ELEV
MDR report key: 3964284
·
Received June 19, 2014
Report
- Report Number
- 2523190-2014-00038
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Date of Event
- March 11, 2014
- Report Date
- May 29, 2014
- Manufacturer
- INTEGRA YORK, PA INC
- Product Code
- DZA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem · 1
CUSTOMER INITIALLY REPORTS BROKEN TIP. (B)(6) 2014 DENTIST REPORTS NO HARM DONE. HE WAS DOING AN EXTRACTION WHEN THE TIP BROKE OFF AND WAS RETRIEVED FROM FLOOR OF MOUTH. GAUZE WAS PREVIOUSLY PLACED AS SCREEN PROTECTOR TO PREVENT SWALLOWING PARTS. NO RADIOGRAPH TAKEN BECAUSE FRAGMENT MATCHED WITH THE ELEVATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360961 | 301 ELEV | M51 - GENERAL DENTISTRY | DZA | INTEGRA YORK, PA INC | GD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR |