FDA Adverse Event
Injury
Summary report: N
REPLANT IMPLANT
MDR report key: 3004002
·
Received March 12, 2013
Report
- Report Number
- 2016150-2013-00007
- Event Type
- Injury
- Date Received
- March 12, 2013
- Date of Event
- February 14, 2013
- Report Date
- February 15, 2013
- Manufacturer
- IMPLANT DIRECT SYBRON MANUFACTURING, LLC
- Product Code
- DZE
- PMA / PMN Number
- K061319
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- AZ, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED AND A VISUAL EVALUATION WAS PERFORMED. THE DEVICE DID NOT MEET SPECIFICATIONS. A CLASS II RECALL WAS INITIATED ON 07/08/2013 WITH REGARD TO THIS INCIDENT.
Description of Event or Problem · 1
A DOCTOR REPORTED ON (B)(6) 2013, THAT A PT'S REPLANT IMPLANT FRACTURED WHEN PLACING THE IMPLANT. IMPLANT WAS EXPLANTED BY IMMEDIATELY DRILLING IT OUT OF THE PT'S MOUTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103810 | REPLANT IMPLANT | IMPLANT, PRODUCT CODE: DZE | DZE | IMPLANT DIRECT SYBRON MANUFACTURING, LLC | 38161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |