FDA Adverse Event
Other
Summary report: N
2.4 X 13MM MDI MAX WITH AN O-BALL HEAD
MDR report key: 1934166
·
Received December 17, 2010
Report
- Report Number
- 2110898-2010-00152
- Event Type
- Other
- Date Received
- December 17, 2010
- Date of Event
- October 26, 2010
- Report Date
- November 1, 2010
- Manufacturer
- 3M ESPE DENTAL PRODUCTS
- Product Code
- DZE
- PMA / PMN Number
- K031106
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS RETURNED TO THE MFR FOR EVAL AND NO VISIBLE ABNORMALITIES IN THE DEVICE WERE NOTED.
Description of Event or Problem · 1
ON (B)(6), 2010, A DENTAL PROFESSIONAL CONTACTED 3M ESPE TO REPORT THAT A DENTAL IMPLANT WAS REMOVED. THE IMPLANT WAS PLACED ON (B)(6) 2009 AND WAS REMOVED ON (B)(6) 2010. THE DENTAL PROFESSIONAL STATED THAT LACK OF PT HYGIENE AND INFECTION WERE THE FACTORS CONTRIBUTING TO THE REMOVAL OF THE IMPLANT. THE DENTAL PROFESSIONAL REPORTED THAT HE REMOVED THE IMPLANT, PERFORMED CURETTAGE OF THE AREA AND A PLACED BONE GRAFT MATERIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2.4 X 13MM MDI MAX WITH AN O-BALL HEAD | DENTAL IMPLANT | DZE | 3M ESPE DENTAL PRODUCTS | S1813MOB | 3505091-10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |