FDA Adverse Event
Injury
Summary report: N
SYBRONPRO TL
MDR report key: 2092513
·
Received May 18, 2011
Report
- Report Number
- 2016150-2011-00075
- Event Type
- Injury
- Date Received
- May 18, 2011
- Date of Event
- June 3, 2010
- Report Date
- April 18, 2011
- Manufacturer
- EBI INC.
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- MD, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
ON (B)(6), 2011 A DOCTOR REPORTED THAT A PATIENT LOST A SYBRONPRO TL IMPLANT APPROXIMATELY TWO (2) MONTHS AFTER PLACEMENT DUE TO THE PATIENT HAVING A LARGE BUCCAL DEFECT. THIS MDR IS THE SECOND OF FIVE (5) REPORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYBRONPRO TL | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | EBI INC. | 071142 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other| R |