FDA Adverse Event
Injury
Summary report: N
2.4 X 13 MM MDI MAX WITH O-BALL HEAD AND COLLAR
MDR report key: 3003874
·
Received March 12, 2013
Report
- Report Number
- 3005174370-2013-00007
- Event Type
- Injury
- Date Received
- March 12, 2013
- Date of Event
- January 22, 2013
- Report Date
- February 28, 2013
- Manufacturer
- 3M ESPE DENTAL PRODUCTS
- Product Code
- DZE
- PMA / PMN Number
- K031106
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE IMPLANT PIECES WERE RETURNED FOR EVAL. EVAL OF THE FRACTURED SURFACES ON THE PIECES SHOWED WITHER TORSIONAL AND/OR CANTILEVER FAILURE.
Description of Event or Problem · 1
ON (B)(6) 2013, 3M ESPE WAS INFORMED OF A CASE WHERE TWO OF THE THREE MDI IMPLANT HEADS FRACTURED DURING PLACEMENT. THE PLACEMENT OCCURRED ON (B)(6) 2013. FOLLOW-UP INFORMATION PROVIDED ON (B)(6) 2013, INDICATES THAT A SURGICAL INTERVENTION PROCEDURE WAS REQUIRED TO REMOVE THE FRACTURED PORTIONS OF THE TWO IMPLANTS; A SURGICAL FLAP WAS RAISED AND THE IMPLANTS WERE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103031 | 2.4 X 13 MM MDI MAX WITH O-BALL HEAD AND COLLAR | DENTAL IMPLANT | DZE | 3M ESPE DENTAL PRODUCTS | MOB-15 | N439690 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |