FDA Adverse Event
Malfunction
Summary report: N
MINIATURE PIN & LIGATURE CUTTER
MDR report key: 2264973
·
Received August 17, 2011
Report
- Report Number
- 2086211-2011-00005
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Report Date
- July 18, 2011
- Manufacturer
- GAC INTERNATIONAL
- Product Code
- EJB
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED FOR EVAL AND WAS FOUND TO HAVE EXCEEDED THE EXPECTED LIFE OF THE DEVICE. WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT REC'D IN PAST TWO YRS INVOLVING A SIMILAR DEVICE WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803.
Description of Event or Problem · 1
IN THIS EVENT IT WAS REPORTED THAT THE TIP OF A MINIATURE PIN AND LIGATURE CUTTER SEPARATED OUTSIDE OF A PT'S MOUTH; THERE IS NO INDICATION THAT INJURY RESULTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINIATURE PIN & LIGATURE CUTTER | EJB | GAC INTERNATIONAL | 03-43 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LIG WIRE (SMALL)| CHAIN LIGS |