FDA Adverse Event
Other
Summary report: N
SCREW IMPLANT 2-P L 12MM, DIAM. 4.1MM
MDR report key: 716810
·
Received May 19, 2006
Report
- Report Number
- 1222315-2006-00001
- Event Type
- Other
- Date Received
- May 19, 2006
- Date of Event
- October 21, 2004
- Report Date
- May 19, 2006
- Manufacturer
- *
- Product Code
- DZE
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
THE SALES REPRESENTATIVE REPORTS THAT THE DOCTOR PLACED AN IMPLANTIN 2004 THAT EXPIRED IN 2002-03 (MARCH, 2002). THERE IS CURRENTLY NO REPORTED PROBLEM WITH THE IMPLANT, AND IT STILL IN THE PT'S MOUTH. SINCE THE LABEL CLEARLY STATES THE STERILIZATION/EXPIRATION DATE THE CLINICIAN SHOULD NOT HAVE PLACED AN EXPIRED IMPLANT WHICH WAS NOT STERILE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREW IMPLANT 2-P L 12MM, DIAM. 4.1MM | ENOSSEOUS DENTAL IMPLANT | DZE | * | NA | 1113 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |