FDA Adverse Event
Injury
Summary report: N
SYBRONPRO XRT
MDR report key: 1740960
·
Received June 29, 2010
Report
- Report Number
- 2016150-2010-00096
- Event Type
- Injury
- Date Received
- June 29, 2010
- Date of Event
- April 21, 2010
- Report Date
- June 22, 2010
- Manufacturer
- EBI INC.
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
ON JUNE 22, 2010, A DOCTOR REPORTED THAT A PATIENT LOST A SYBRONPRO XRT IMPLANT SIX (6) MONTHS AFTER PLACEMENT DUE TO UNKNOWN CAUSES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYBRONPRO XRT | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | EBI INC. | 091110/093119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other| R |