FDA Adverse Event
Injury
Summary report: N
TRABECULAR METAL IMPLANT
MDR report key: 2543742
·
Received April 20, 2012
Report
- Report Number
- 2023141-2012-00001
- Event Type
- Injury
- Date Received
- April 20, 2012
- Date of Event
- February 28, 2012
- Report Date
- March 20, 2012
- Manufacturer
- ZIMMER DENTAL INC
- Product Code
- DZE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
DURING INSERTION OF IMPLANT INTO RESORBED MANDIBLE WITH EXTREMELY DENSE INFERIOR ORDER, APICAL END OF IMPLANT BECAME JAMMED IN THE BONE AND UPON CONTINUED APPLICATION OF TORQUE SEPARATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRABECULAR METAL IMPLANT | DZE | ZIMMER DENTAL INC | TMM4B13 | 61973167 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |