FDA Adverse Event
Other
Summary report: N
1.1MM MDI SURGICAL DRILL (STERILE)
MDR report key: 2625761
·
Received June 13, 2012
Report
- Report Number
- 3005174370-2012-00014
- Event Type
- Other
- Date Received
- June 13, 2012
- Date of Event
- April 9, 2012
- Report Date
- May 15, 2012
- Manufacturer
- 3M ESPE DENTAL PRODUCTS
- Product Code
- DZA
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
ON 05/15/2012, 3M ESPE WAS INFORMED OF A CASE IN WHICH THREE S1011 DRILLS BROKE DURING PLACEMENT OF IMPLANTS IN A (B)(6) MALE PT. ALL THREE BROKEN DRILL FRAGMENTS WERE LEFT IN PLACE. NO INFO ON THE DENSITY OF THE PT'S BONE WAS PROVIDED TO 3M ESPE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1.1MM MDI SURGICAL DRILL (STERILE) | DENTAL DRILL | DZA | 3M ESPE DENTAL PRODUCTS | S1011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other |